The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Bicarbonate (co2) Uv Hp).
Device ID | K874941 |
510k Number | K874941 |
Device Name: | BIOTROL BICARBONATE (CO2) UV HP) |
Classification | Enzymatic, Carbon-dioxide |
Applicant | BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern, PA 19355 |
Contact | Allan C Murphy |
Correspondent | Allan C Murphy BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern, PA 19355 |
Product Code | KHS |
CFR Regulation Number | 862.1160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-02 |
Decision Date | 1988-01-05 |