The following data is part of a premarket notification filed by Cm Technologies, Inc. with the FDA for Qora Stool Management Kit.
| Device ID | K212444 |
| 510k Number | K212444 |
| Device Name: | Qora Stool Management Kit |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CM Technologies, Inc. 2165 San Diego Avenue San Diego, CA 92110 |
| Contact | Nishith Chasmawala |
| Correspondent | Alan Donald Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, CA 92108 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-05 |
| Decision Date | 2021-11-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() QORA STOOL MANAGEMENT KIT 87775727 5672743 Live/Registered |
Consure Medical Private Limited 2018-01-30 |