2C7125 BLOW BOTTLE
FDA 510(k) clearance K780407 · decided 1978-04-10
Clearance details
- K-number
- K780407
- Device name
- 2C7125 BLOW BOTTLE
- Applicant
- Travenol Laboratories, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-13
- Decision date
- 1978-04-10
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- BYO
- Device class
- 1
- Regulation number
- 868.5220
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, 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 |
|---|---|---|
| EPIDURAL MINIPACK (K924541) | Concord/Portex | 1993-07-09 |
| HYPERFREE (K913527) | Kist Intl. | 1992-01-21 |
| BOTTLE BREATHING DEVICE (K780558) | B & F Medical Products, Inc. | 1978-05-26 |
Recalls involving this device
No recalls on record reference this clearance.