# K981394: Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720

- Pathway: 510(k) (Traditional)
- Applicant: Braemar Corp.
- Decided: Sep 28, 1998 after 164 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- 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 K923930 (1992). 1 ancestor in all.
51 later devices descend from it; 3 cite it directly.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923930: Electrocardiograph Transmitter, Tz Medical, Inc. (1992) Summary page 4.

## Most influential descendants
- K042022: E-Tac EX-1000 Electrocardiographic Event Recorder (2004), 42 descendants of its own
- K090696: Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System (2009), 40 descendants of its own
- K091971: Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT) System (2009), 38 descendants of its own
- K111917: Nuvant, Mobile Cardiac Telemetry (2011), 30 descendants of its own
- K113372: Nuvant, Mobilc Cardiac Telemetry (2012), 24 descendants of its own

## Indications for use
To record infrequent and elusive ECG heart arrhythmia data. Once an event is recorded, patients transmit the recorded ECG data over the telephone. Or, as an alternative, the ER700 Series allows the ECG data to be transferred directly to a host PC if the patient returns the unit to the clinic.

Source page: https://510kreport.com/device/K981394
Methodology: https://510kreport.com/methodology