# K983576: DR180-R/Oxy

- Pathway: 510(k) (Traditional)
- Applicant: North East Monitoring, Inc.
- Decided: Mar 23, 1999 after 161 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960925 (1996). 1 ancestor in all.
40 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960925: Northeast Monitoring DR180, North East Monitoring, Inc. (1996) Summary page 1.

## Most influential descendants
- K022274: Carecompanion Patient Station & Nurse Station (2003), 39 descendants of its own
- K041308: Remotenurse Patient Monitoring System (2004), 34 descendants of its own
- K080798: Intel Health Guide, Model: PHS6000 (2008), 25 descendants of its own
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own
- K083115: Modification to Intel Health Guide, Model PHS6000 (2008), 12 descendants of its own

## Indications for use
1.) Detection of Arrhythmias: The NorthEast Monitoring DR180-R/Oxy is indicated for use for long-term monitoring of cardiac rhythm when intermittent arrhythmias are suspected due to patient symptoms such as palpitations, transient ischemic attacks (TIA’s), syncope (fainting), or other such symptoms as determined by the physician. 2.) Efficacy of Treatment: The NorthEast Monitoring DR180-R/Oxy is indicated for use to determine if current pharmacological treatment of known arrhythmias is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment. 3.) Pacemaker Evaluation: The NorthEast Monitoring DR180-R/Oxy is indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. '4.) Trending of oxygen saturation (SpO2) in the blood for periods of up to 24 hours. If the device is to be used for home monitoring, periods of activity or excessive movement are to be omitted due to the artifact that would be generated. 3.) The NorthEast Monitoring DR180-R/Oxy is to be used only on the order of a physician.

Source page: https://510kreport.com/device/K983576
Methodology: https://510kreport.com/methodology