The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Bottle Breathing Device.
| Device ID | K780558 |
| 510k Number | K780558 |
| Device Name: | BOTTLE BREATHING DEVICE |
| Classification | Bottle, Blow |
| Applicant | B & F MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYO |
| CFR Regulation Number | 868.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-04-05 |
| Decision Date | 1978-05-26 |