NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
FDA 510(k) clearance K952328 · decided 1995-09-29
Clearance details
- K-number
- K952328
- Device name
- NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1995-05-18
- Decision date
- 1995-09-29
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- DXY
- Device class
- 3
- Regulation number
- 870.3610
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.