The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Homechoice Claria Apd System, Sharesource Connectivity Platform For Use With The Homechoice Claria Apd System.
| Device ID | K201867 |
| 510k Number | K201867 |
| Device Name: | Homechoice Claria APD System, Sharesource Connectivity Platform For Use With The Homechoice Claria APD System |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | Baxter Healthcare Corporation 25212 W. Illinois Route 120 Round Lake, IL 60073 |
| Contact | Brad Roynon |
| Correspondent | Brad Roynon Baxter Healthcare Corporation 25212 W. Illinois Route 120 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 | 2020-07-07 |
| Decision Date | 2020-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412676468 | K201867 | 000 |