CAPNO PROBE A
FDA 510(k) clearance K984579 · decided 2000-12-21
Clearance details
- K-number
- K984579
- Device name
- CAPNO PROBE A
- Applicant
- Optical Sensors, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-23
- Decision date
- 2000-12-21
- Days to decision
- 729 days
- Clearance type
- Traditional
- Product code
- CCK
- Device class
- 2
- Regulation number
- 868.1400
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.