# K973527: Cardio-Pager System

- Pathway: 510(k) (Traditional)
- Applicant: Data Critical Corp.
- Decided: Mar 31, 1998 after 194 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: 2 generations back to K962827 (1997). 3 ancestors in all.
57 later devices descend from it; 1 cites 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)
- K962827: Alarm Display Unit/Pager-Lan System (Adu), Marquette Electronics, Inc. (1997) Summary page 1.
- K945277: Hewlett-Packard Model M1490A Wireless Patient Data Communicator, Hewlett-Packard Co. (1995) Summary page 1.
- K971868: Impact (Informing Mobile Personnel and Care Tracking) Pager System, Marquette Electronics, Inc. (1997). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K992749: Ultraview Waveform Pager System, Model 91841 (2000), 56 descendants of its own
- 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

## Indications for use
The Cardio-Pager™ System described in this submission is a paging system that interfaces with primary patient monitoring systems in order to provide a secondary means of annunciating and displaying patient alarm information to mobile health care providers. The Cardio-Pager™ System has been validated for use with the Marquette Unity Network and the Hewlett-Packard System CareNet. This pager is intended to serve as a parallel, redundant mechanism to inform the clinical staff of patient events. This device is indicated for use in real-time monitoring of routine patient status and alarm events. The Cardio-Pager™ is limited to use by qualified medical professionals who have been trained on the use of the device. It is intended for use only in a hospital environment.

Source page: https://510kreport.com/device/K973527
Methodology: https://510kreport.com/methodology