GAS SAMPLING INTERFACES
FDA 510(k) clearance K943110 · decided 1994-08-19
Clearance details
- K-number
- K943110
- Device name
- GAS SAMPLING INTERFACES
- Applicant
- Coast Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-29
- Decision date
- 1994-08-19
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- BYX
- Device class
- 1
- Regulation number
- 868.5860
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Orange, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.