The following data is part of a premarket notification filed by Physio-control Corp. with the FDA for Adr-10600(adr 400),10601 (adr 300).
| Device ID | K791342 |
| 510k Number | K791342 |
| Device Name: | ADR-10600(ADR 400),10601 (ADR 300) |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | PHYSIO-CONTROL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-17 |
| Decision Date | 1979-11-16 |