The following data is part of a premarket notification filed by Arc Medical, Inc. with the FDA for Filterflo H.
| Device ID | K011212 |
| 510k Number | K011212 |
| Device Name: | FILTERFLO H |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | ARC MEDICAL, INC. 322 PATTERSON AVE. Scottdale, GA 30079 |
| Contact | Hal Norris |
| Correspondent | Hal Norris ARC MEDICAL, INC. 322 PATTERSON AVE. Scottdale, GA 30079 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-20 |
| Decision Date | 2001-12-20 |