PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)
FDA 510(k) clearance K944451 · decided 1995-07-07
Clearance details
- K-number
- K944451
- Device name
- PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)
- Applicant
- Passy-Muir, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-09-12
- Decision date
- 1995-07-07
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- JOH
- Device class
- 2
- Regulation number
- 868.5800
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.