The following data is part of a premarket notification filed by Bio-med Devices, Inc. with the FDA for Cbg Cuff Manometer.
Device ID | K873614 |
510k Number | K873614 |
Device Name: | CBG CUFF MANOMETER |
Classification | Cuff, Tracheal Tube, Inflatable |
Applicant | BIO-MED DEVICES, INC. 8 BISHOP LN. Madison, CT 06443 |
Contact | Dean J Bennett |
Correspondent | Dean J Bennett BIO-MED DEVICES, INC. 8 BISHOP LN. Madison, CT 06443 |
Product Code | BSK |
CFR Regulation Number | 868.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-08 |
Decision Date | 1988-01-22 |