The following data is part of a premarket notification filed by A-m Systems with the FDA for Hyrdromax Hmef.
| Device ID | K130664 |
| 510k Number | K130664 |
| Device Name: | HYRDROMAX HMEF |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | A-M SYSTEMS 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden A-M SYSTEMS 24301 WOODSAGE DR. 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 | 2013-03-12 |
| Decision Date | 2013-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817081020502 | K130664 | 000 |
| 00817081026726 | K130664 | 000 |