OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
FDA 510(k) clearance K882476 · decided 1988-09-12
Clearance details
- K-number
- K882476
- Device name
- OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
- Applicant
- Ela Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-06-15
- Decision date
- 1988-09-12
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- DXY
- Device class
- 3
- Regulation number
- 870.3610
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.