PIKOS E 01-B
FDA 510(k) clearance K941937 · decided 1994-08-30
Clearance details
- K-number
- K941937
- Device name
- PIKOS E 01-B
- Applicant
- Biotronik, Inc.
- Decision
- Unknown
- Date received
- 1994-04-21
- Decision date
- 1994-08-30
- Days to decision
- 131 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.