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 |