OPTI- SYSTEM
FDA 510(k) clearance K810559 · decided 1981-03-17
Clearance details
- K-number
- K810559
- Device name
- OPTI- SYSTEM
- Applicant
- Corpak Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-03
- Decision date
- 1981-03-17
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.