The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Personal Cycler Autommated Peritoneal Dial.
| Device ID | K923065 |
| 510k Number | K923065 |
| Device Name: | BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | David C Ross |
| Correspondent | David C Ross BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-25 |
| Decision Date | 1994-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412087370 | K923065 | 000 |
| 50085412050824 | K923065 | 000 |
| 50085412007712 | K923065 | 000 |