510(k) K132764
K132764 is an FDA 510(k) premarket notification submitted by Camntech, Ltd. for the device "MOTION WATCH AND PRO-DIARY". The FDA issued a decision of Substantially Equivalent on January 21, 2014. The device falls under product code LEL (Device, Sleep Assessment), a Class II device regulated under 21 CFR 882.5050. Camntech, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2014
- Date Received
- September 4, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Sleep Assessment
- Device Class
- Class II
- Regulation Number
- 882.5050
- Review Panel
- NE
- Submission Type