PHONATORY FUNCTION ANALYZER PS-77
FDA 510(k) clearance K832678 · decided 1984-03-07
Clearance details
- K-number
- K832678
- Device name
- PHONATORY FUNCTION ANALYZER PS-77
- Applicant
- Kells Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-09
- Decision date
- 1984-03-07
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- BXP
- Device class
- 1
- Regulation number
- 868.2885
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| OXYGEN TWMER, MODEL SST (K770424) | Timeter Instrument Corp. | 1977-03-16 |
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Recalls involving this device
No recalls on record reference this clearance.