The following data is part of a premarket notification filed by Arc Medical, Inc. with the FDA for Filterflo Hepa; Thermoflo Hepa (filter / Hme).
| Device ID | K063125 |
| 510k Number | K063125 |
| Device Name: | FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | ARC MEDICAL, INC. 3460 POINTE CREEK COURT # 102 Bonita Springs, FL 34134 -2015 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ARC MEDICAL, INC. 3460 POINTE CREEK COURT # 102 Bonita Springs, FL 34134 -2015 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-13 |
| Decision Date | 2007-04-13 |