Braemar Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 10
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Braemar Corp. makes
Braemar Corp. manufactures portable cardiac monitoring devices, including ambulatory ECG event recorders, Holter recorders, and ambulatory electrocardiographic recorders designed for continuous or intermittent heart rhythm monitoring.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- 510(k) 510(k)
ER800 Series Ecg Event Recorder Ref K030856
510(k) 510(k)- 510(k) 510(k)
DXP1000 Holter Recorder Ref K993618
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
DL900 Series Holter Recorder Ref K071733
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Digitrakplus Holter Recorder Ref K993617
510(k) 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by Braemar Corp., the earliest on 2011-05-02 and the most recent on 2012-02-24. By recorded status: 2 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 24 Feb 2012 Z-1652-2013 Class II Terminated Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. The event did not result in any patient related injury or present any clinical impact.
2011
- 2 May 2011 Z-1645-2013 Class II Terminated Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result in any patient related injury or present any clinical impact.
Frequently asked questions
How many devices does Braemar Corp. have in the registry?
The registry currently lists 10 devices for Braemar Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Braemar Corp.'s devices?
Among its 10 most recently registered devices, Braemar Corp. has devices listed in FDA 510(k) (10 devices).
What risk classes do Braemar Corp.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Braemar Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Braemar Corp.?
FDA recall records list 2 recalls initiated by Braemar Corp., the most recent initiated on 2012-02-24. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Braemar Corp. in the registry?
The most recently registered devices listed for Braemar Corp. include BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER, ER800 SERIES ECG EVENT RECORDER, BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER and DXP1000 HOLTER RECORDER.