# K992749: Ultraview Waveform Pager System, Model 91841

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Jan 14, 2000 after 151 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K962827 (1997). 4 ancestors in all.
56 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973527: Cardio-Pager System, Data Critical Corp. (1998) Summary page 1.
- K971868: Impact (Informing Mobile Personnel and Care Tracking) Pager System, Marquette Electronics, Inc. (1997). Our OCR of the scanned summary read K971808, FDA’s number for Space Chamber for Model Number and Accessories (Monarch Medical). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Marquette Medical Systems Impact Pager System”.

## Most influential descendants
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own
- K090094: Zeltiq System (2009), 32 descendants of its own
- K120023: Zeltiq Coolsculpting (2012), 31 descendants of its own
- K133212: Zeltiq Coolsculpting System (2014), 30 descendants of its own
- K142491: ZEL TIQ CoolSculpting System (2015), 27 descendants of its own

## Indications for use
The intended use of the Spacelabs Medical Ultraview™ Waveform Pager System is to interface with the Spacelabs monitoring network in order to provide a secondary means of annunciating and displaying patient alarm information to mobile healthcare providers. The device is indicated for use in real-time monitoring of routine patient status and alarm events. The pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. The Ultraview™ Waveform Pager System is intended for use as a secondary alarm in any hospital environment currently using or intending to use a Spacelabs patient-monitoring network. The Waveform Paging System supplements the primary patient-monitoring system by providing a forwarding mechanism for annunciating and displaying patient alarm events and the critical information associated with the events - including parameter values and waveforms, typically within 4 - 8 seconds of an alarm event on the patient monitor. The pager provides an audio or vibrating alert along with a series of displays showing patient identification, alarm parameters, and up to a 12-second waveform snapshot. The Spacelabs Medical Ultraview™ Waveform Pager System is a secondary alarm. It does not replace the primary alarm function on the monitor.

Source page: https://510kreport.com/device/K992749
Methodology: https://510kreport.com/methodology