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 |