510(k) K173046
K173046 is an FDA 510(k) premarket notification submitted by Dexcowin Co., Ltd. for the device "Cocoon Portable Handheld X-Ray System". The FDA issued a decision of Substantially Equivalent on Oct 26, 2017. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Dexcowin Co., Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 26, 2017
- Date Received
- Sep 28, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type
- 510(k)