SHERWOOD VENTILATORY MUSCLE TRAINER
FDA 510(k) clearance K802165 · decided 1980-09-26
Clearance details
- K-number
- K802165
- Device name
- SHERWOOD VENTILATORY MUSCLE TRAINER
- Applicant
- Sherwood Medical Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-08
- Decision date
- 1980-09-26
- Days to decision
- 18 days
- Clearance type
- Traditional
- Product code
- BYW
- Device class
- 1
- Regulation number
- 868.5675
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- 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 |
|---|---|---|
| HYPEX (K895274) | Global Business, Inc. | 1990-02-23 |
Recalls involving this device
No recalls on record reference this clearance.