FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR
K Number: K870142
·
Decision Apr 22, 1987
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
3
Review Days
99
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Basic Information
- Device Name
- PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR
- K Number
- K870142
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cardio-Pace Medical, Inc.
- Date Received
- January 13, 1987
- Decision Date
- April 22, 1987
- Product Code
- DXY
- 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 |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
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