WHISPER O2
FDA 510(k) clearance K931355 · decided 1994-03-25
Clearance details
- K-number
- K931355
- Device name
- WHISPER O2
- Applicant
- Trilogic Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-17
- Decision date
- 1994-03-25
- Days to decision
- 373 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.