The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Homechoice/homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5c4471, 5c8310, 5c4471r And 5c8310r.
| Device ID | K102936 |
| 510k Number | K102936 |
| Device Name: | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | David E Curtin |
| Correspondent | David E Curtin BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-04 |
| Decision Date | 2011-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412090073 | K102936 | 000 |
| 50085412088438 | K102936 | 000 |
| 50085412087677 | K102936 | 000 |
| 00085412079165 | K102936 | 000 |
| 00085412026350 | K102936 | 000 |
| 00085412007038 | K102936 | 000 |
| 00085412007021 | K102936 | 000 |