PRESSURE MONITOR & CONTROL UNIT APC-02A
FDA 510(k) clearance K831402 · decided 1983-08-08
Clearance details
- K-number
- K831402
- Device name
- PRESSURE MONITOR & CONTROL UNIT APC-02A
- Applicant
- Parker Hannifin Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-02
- Decision date
- 1983-08-08
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- KXM
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, 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 |
|---|---|---|
| BAXTER BIOSTAT 1000 UREA MONITOR (K925581) | Baxter Healthcare Corp | 1995-05-03 |
| COLORADO MEDICAL MODEL PTC 1000 (K863471) | Colorado Medical, Inc. | 1986-10-02 |
| VELCRO FISTULA PRESSURE CLAMPS (K853536) | Cp Medical | 1985-10-17 |
Recalls involving this device
No recalls on record reference this clearance.