The following data is part of a premarket notification filed by B & B Medical Technologies, Inc. with the FDA for Bodai Neo2-safe(tm).
Device ID | K873696 |
510k Number | K873696 |
Device Name: | BODAI NEO2-SAFE(TM) |
Classification | Connector, Airway (extension) |
Applicant | B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
Contact | Briggs Iii |
Correspondent | Briggs Iii B & B MEDICAL TECHNOLOGIES, INC. P.O. BOX 1503 Orangevale, CA 95662 |
Product Code | BZA |
CFR Regulation Number | 868.5810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-14 |
Decision Date | 1988-04-14 |