The following data is part of a premarket notification filed by A-m Systems, Inc. with the FDA for Vbmax.
Device ID | K000654 |
510k Number | K000654 |
Device Name: | VBMAX |
Classification | Filter, Bacterial, Breathing-circuit |
Applicant | A-M SYSTEMS, INC. 131 BUSINESS PARK LOOP P.O. BOX 850 Carlsborg, WA 98324 |
Contact | Steve Grasser |
Correspondent | Steve Grasser A-M SYSTEMS, INC. 131 BUSINESS PARK LOOP P.O. BOX 850 Carlsborg, WA 98324 |
Product Code | CAH |
CFR Regulation Number | 868.5260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-28 |
Decision Date | 2000-11-14 |