The following data is part of a premarket notification filed by Physicians Software Systems, Llc with the FDA for Physoft Ams.
| Device ID | K130579 |
| 510k Number | K130579 |
| Device Name: | PHYSOFT AMS |
| Classification | System, Hemodialysis, Access Recirculation Monitoring |
| Applicant | PHYSICIANS SOFTWARE SYSTEMS, LLC 3333 WARRENVILLE ROAD SUITE 200 Lisle, IL 60532 |
| Contact | Lewis A Mitchell |
| Correspondent | Lewis A Mitchell PHYSICIANS SOFTWARE SYSTEMS, LLC 3333 WARRENVILLE ROAD SUITE 200 Lisle, IL 60532 |
| Product Code | MQS |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-05 |
| Decision Date | 2013-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861858000303 | K130579 | 000 |