The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Portable Oxygen Unit.
| Device ID | K853004 |
| 510k Number | K853004 |
| Device Name: | PORTABLE OXYGEN UNIT |
| Classification | Generator, Oxygen, Portable |
| Applicant | B & F MEDICAL PRODUCTS, INC. 1421 N. EXPRESSWAY DR. Toledo, OH 43608 |
| Contact | Jim Spillis |
| Correspondent | Jim Spillis B & F MEDICAL PRODUCTS, INC. 1421 N. EXPRESSWAY DR. Toledo, OH 43608 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-16 |
| Decision Date | 1985-08-29 |