PhySoftAMS®
FDA 510(k) clearance K232283 · decided 2023-12-14
Clearance details
- K-number
- K232283
- Device name
- PhySoftAMS®
- Applicant
- Physician Software Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-07-31
- Decision date
- 2023-12-14
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- MQS
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Lisle, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dosis SAM (K180410) | Dosis, Inc. | 2019-01-16 |
| PHYSOFT AMS (K130579) | Physicians Software Systems, LLC | 2013-12-19 |
| VASC-ALERT (K042566) | Vasc-Alert, Inc. | 2004-11-08 |
| TRANSONIC SYRINGE WARMER, MODEL SYR-1000 (K022963) | Transonic Systems, Inc. | 2002-12-04 |
| TRANSONIC FLOW-QC SET MODEL ADT1010 (K021571) | Transonic Systems, Inc. | 2002-08-12 |
| CRIT-LINE MONITOR III (CLM III) (K001763) | In-Line Diagnostics Corp. | 2000-12-20 |
| HP M2376A DEVICE LINK SYSTEM (K993587) | Hewlett-Packard Co. | 2000-01-20 |
| CRIT-LINE MONITOR III (CLM III) (K992227) | In-Line Diagnostics Corp. | 1999-07-30 |
| HP M2376A DEVICE LINK SYSTEM (K984194) | Hewlett-Packard Co. | 1999-04-30 |
| MODIFICATION OF CRIT-LINE MONITOR III (CLM III) (K982412) | In-Line Diagnostics Corp. | 1998-10-09 |
| TRANSONIC HEMODIALYSIS MONITOR, CARDIAC OUTPUT, MODEL HD01-CO (K980906) | Transonic Systems, Inc. | 1998-10-06 |
| CRIT-LINE MONITOR (CLMIII) (K972470) | In-Line Diagnostics Corp. | 1997-12-11 |
Recalls involving this device
No recalls on record reference this clearance.