The following data is part of a premarket notification filed by A-m Systems, Inc. with the FDA for A-m Systems Viromax Viral And Bacterial Filter.
| Device ID | K063526 |
| 510k Number | K063526 |
| Device Name: | A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | A-M SYSTEMS, INC. 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-22 |
| Decision Date | 2007-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817081020304 | K063526 | 000 |
| 00817081022582 | K063526 | 000 |
| 00817081025859 | K063526 | 000 |
| 00817081027280 | K063526 | 000 |