BOTTLE BREATHING DEVICE
FDA 510(k) clearance K780558 · decided 1978-05-26
Clearance details
- K-number
- K780558
- Device name
- BOTTLE BREATHING DEVICE
- Applicant
- B & F Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-04-05
- Decision date
- 1978-05-26
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- BYO
- Device class
- 1
- Regulation number
- 868.5220
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch B & F Medical Products
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 2C7125 BLOW BOTTLE (K780407) | Travenol Laboratories, S.A. | 1978-04-10 |
Recalls involving this device
No recalls on record reference this clearance.