510(k) K212444
K212444 is an FDA 510(k) premarket notification submitted by Cm Technologies, Inc. for the device "Qora Stool Management Kit". The FDA issued a decision of Substantially Equivalent on Nov 17, 2021. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Cm Technologies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 17, 2021
- Date Received
- Aug 5, 2021
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type