BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720— 510(k) K981394
Substantially EquivalentBraemar Corp.
FDA 510(k) clearance K981394 for BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720, Substantially Equivalent on 1998-09-28. Applicant: Braemar Corp.. Device class: 2.
Clearance details
- Applicant
- Braemar Corp.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnsville, MN, US
Recent devices under product code DXH
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