The following data is part of a premarket notification filed by B & F Medical Products, Inc. with the FDA for Maxi-use O2 Device.
Device ID | K861325 |
510k Number | K861325 |
Device Name: | MAXI-USE O2 DEVICE |
Classification | Conserver, Oxygen |
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 | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-09 |
Decision Date | 1986-09-09 |