FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRACKER-2 CHANNEL ECG TAPE RECORDER
K Number: K821516
·
Decision May 28, 1982
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
12
Review Days
7
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Basic Information
- Device Name
- TRACKER-2 CHANNEL ECG TAPE RECORDER
- K Number
- K821516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Reynolds Medical , Ltd.
- Date Received
- May 21, 1982
- Decision Date
- May 28, 1982
- 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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