The following data is part of a premarket notification filed by Parker Hannifin Corp. with the FDA for Pressure Monitor & Control Unit Apc-02a.
| Device ID | K831402 |
| 510k Number | K831402 |
| Device Name: | PRESSURE MONITOR & CONTROL UNIT APC-02A |
| Classification | System Accessories, Extracorporeal |
| Applicant | PARKER HANNIFIN CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KXM |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-02 |
| Decision Date | 1983-08-08 |