The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Peritoneal Dialysis System.
| Device ID | K760724 |
| 510k Number | K760724 |
| Device Name: | PERITONEAL DIALYSIS SYSTEM |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-27 |
| Decision Date | 1976-11-23 |