FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SERIES 7000/HOLTER RECORDER
K Number: K851971
·
Decision Jun 20, 1985
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
30
Review Days
44
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Basic Information
- Device Name
- SERIES 7000/HOLTER RECORDER
- K Number
- K851971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Pfizer, Inc.
- Date Received
- May 7, 1985
- Decision Date
- June 20, 1985
- 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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