The following data is part of a premarket notification filed by Biomedical Devices, Inc. with the FDA for Bmd Air/oxygen Blender.
Device ID | K925982 |
510k Number | K925982 |
Device Name: | BMD AIR/OXYGEN BLENDER |
Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
Applicant | BIOMEDICAL DEVICES, INC. 8 BISHOP LN. Madison, CT 06443 |
Contact | Dean J Bennett |
Correspondent | Dean J Bennett BIOMEDICAL DEVICES, INC. 8 BISHOP LN. Madison, CT 06443 |
Product Code | BZR |
CFR Regulation Number | 868.5330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-25 |
Decision Date | 1993-10-07 |