PhySoftAMS®
FDA 510(k) K232283 · Physician Software Systems, LLC
510(k) numberK232283
Submission
- Device name
- PhySoftAMS®
- Applicant
- Physician Software Systems, LLC
Lisle, IL, US - Received
- July 31, 2023
- Decision date
- December 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQS – System, Hemodialysis, Access Recirculation Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code MQS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180410 | Dosis SAMMQS · Traditional | Dosis, Inc. | 01/16/2019SE |
| K130579 | Physoft AmsMQS · Traditional | Physicians Software Systems, LLC | 12/19/2013SE |
| K042566 | Vasc-AlertMQS · Traditional | Vasc-Alert, Inc. | 11/08/2004SE |
| K022963 | Transonic Syringe Warmer, Model SYR-1000MQS · Traditional | Transonic Systems, Inc. | 12/04/2002SE |
| K021571 | Transonic Flow-Qc Set Model ADT1010MQS · Traditional | Transonic Systems, Inc. | 08/12/2002SE |
| K001763 | Crit-Line Monitor III (CLM III)MQS · Traditional | In-Line Diagnostics Corp. | 12/20/2000SE |
| K993587 | HP M2376A Device Link SystemMQS · Traditional | Hewlett-Packard Co. | 01/20/2000SE |
| K992227 | Crit-Line Monitor III (CLM III)MQS · Special | In-Line Diagnostics Corp. | 07/30/1999SE |
| K984194 | HP M2376A Device Link SystemMQS · Traditional | Hewlett-Packard Co. | 04/30/1999SE |
| K982412 | Modification of Crit-Line Monitor III (CLM III)MQS · Traditional | In-Line Diagnostics Corp. | 10/09/1998SE |
Questions and answers
When was PhySoftAMS® cleared by the FDA?
PhySoftAMS® (K232283) received a 510(k) decision of Substantially Equivalent on December 14, 2023, 136 days after the submission was received.
What is the product code of K232283?
The FDA product code is MQS – System, Hemodialysis, Access Recirculation Monitoring, a Class II (moderate risk) device regulated under 21 CFR 876.5820.