# K071011: Modification to: Braemar ER900 Series Enhanced Algorithm Ecg Event Recorder

- Pathway: 510(k) (Special)
- Applicant: Braemar, Inc.
- Decided: Apr 27, 2007 after 17 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K112601: Intricon Datrix Sirona Event/ Holter Recorder (2011), 0 descendants of its own

## Indications for use
The device is indicated for diagnostic evaluation of patients who experience transient symptoms such as; dizziness, palpitations, syncope, or chest pain. The device is intended to record cardiac activity associated with these infrequent and transient symptoms. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review by a licensed physician.

Source page: https://510kreport.com/device/K071011
Methodology: https://510kreport.com/methodology