FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER
K Number: K945130
·
Decision Apr 12, 1995
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
5
Review Days
175
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Basic Information
- Device Name
- BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER
- K Number
- K945130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Braemar Corp.
- Date Received
- October 19, 1994
- Decision Date
- April 12, 1995
- Product Code
- DSH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Braemar Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K030856 | ER800 SERIES ECG EVENT RECORDER | Mar 28, 2003 | Substantially Equivalent |
| K993618 | DXP1000 HOLTER RECORDER | Nov 24, 1999 | Substantially Equivalent |
| K993617 | DIGITRAKPLUS HOLTER RECORDER | Nov 24, 1999 | Substantially Equivalent |
| K981394 | BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720 | Sep 28, 1998 | Substantially Equivalent |