The following data is part of a premarket notification filed by Arc Medical, Inc. with the FDA for Thermoflo Hch, Thermoflo Filter.
| Device ID | K090738 |
| 510k Number | K090738 |
| Device Name: | THERMOFLO HCH, THERMOFLO FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | ARC MEDICAL, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ARC MEDICAL, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-20 |
| Decision Date | 2009-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50850015328065 | K090738 | 000 |
| 10810050852200 | K090738 | 000 |
| 10810050852217 | K090738 | 000 |
| 10810050853689 | K090738 | 000 |
| 20850015328002 | K090738 | 000 |
| 40850015328013 | K090738 | 000 |
| 50850015328027 | K090738 | 000 |
| 40850015328037 | K090738 | 000 |
| 40850015328044 | K090738 | 000 |
| 40850015328051 | K090738 | 000 |
| 10810050853863 | K090738 | 000 |