The following data is part of a premarket notification filed by Cloudcath with the FDA for Cloudcath Peritoneal Dialysis Drain Set Monitoring System.
| Device ID | K212658 |
| 510k Number | K212658 |
| Device Name: | CloudCath Peritoneal Dialysis Drain Set Monitoring System |
| Classification | System, Peritoneal, Automatic Delivery |
| Applicant | CloudCath 665 3rd Street, Suite 250 San Francisco, CA 94107 |
| Contact | Brian Fisher |
| Correspondent | Brian Fisher CloudCath 665 3rd Street, Suite 250 San Francisco, CA 94107 |
| Product Code | FKX |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2022-02-09 |