# K983996: Spacelabs Medical Ultraview Digital Telemtry System

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Jun 3, 1999 after 205 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K933143 (1994). 17 ancestors in all.
26 later devices descend from it; 3 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972502: Spacelabs Medical Integrated Multiparameter Module 90496, Spacelabs Medical, Inc. (1998) Summary page 1.
- K855127: Ambulatory Blood Pressure Monitor Spacelabs #90202, Spacelabs, Inc. (1986) Summary page 2.
- K952885: Single Lead Digital Telemetry Transmitter, Spacelabs Medical, Inc. (1995) Summary page 2.
- K925510: Model 90478 & 90479 Telemetry Rec. Module&Housing, Spacelabs Medical, Inc. (1994) Summary page 2.
- K781836: Telemetry System, Biotel 300, Spacelabs, Inc. (1978) Summary page 2.
- K961165: HP M2600A Omnicare Telemetry System Model M2600A, Hewlett-Packard Co. (1996) Summary page 2.

## Most influential descendants
- K080192: Hypervisor VI Central Monitoring System (Including TMS) (2008), 20 descendants of its own
- K132036: Hypervisor Central Monitoring System (Including Telemetry Monitoring System, TMS-6016) (2014), 17 descendants of its own
- K150632: Hypervisor IX Monitoring System (2015), 14 descendants of its own
- K162607: BeneVision Central Monitoring System (2017), 12 descendants of its own
- K183238: BeneVision Central Monitoring System (2019), 11 descendants of its own

## Indications for use
The Spacelabs Medical Ultraview Digital Telemetry System, when used in conjunction with a Spacelabs Medical PCMS Patient Monitor or Ultraview Care Network, provides a means for the continuous monitoring of electrocardiographic signals in order to detect abnormal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole, and ventricular fibrillation. Optionally, on adult patients, additional abnormal cardiac rhythms, such as ventricular runs, tachycardia, and ST segment deviations are detected. The Ultraview Digital Telemetry System also provides a means for the episodic monitoring of noninvasive blood pressure (NIBP) signals to detect abnormal events such as high and low blood pressure. The System also provides a means for both continuous and episodic monitoring of pulse blood oxygen saturation signals in order to detect desaturation caused by abnormal pulmonary/circulatory functions. The Spacelabs Medical Ultraview Digital Telemetry System Models 90343 and 90347 are intended for use with either adult or neonatal patient populations in a hospital environment. When the NIBP option is selected in the Model 90343 configuration, the NIBP feature is to be used with adult patient populations only.

Source page: https://510kreport.com/device/K983996
Methodology: https://510kreport.com/methodology