PNEUMOTACHOGRAPHY SYSTEM
FDA 510(k) clearance K760816 · decided 1976-10-29
Clearance details
- K-number
- K760816
- Device name
- PNEUMOTACHOGRAPHY SYSTEM
- Applicant
- Aftercal, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-10-12
- Decision date
- 1976-10-29
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- GWB
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CODMAN GAAB NEUROENDOSCOPE (K923555) | Codman & Shurtleff, Inc. | 1993-03-23 |
Recalls involving this device
No recalls on record reference this clearance.