510(k) K112951
K112951 is an FDA 510(k) premarket notification submitted by Shenzhen Healthcare Electronic Technology Co., Ltd. for the device "BODY ANALYSIS SCALE". The FDA issued a decision of Substantially Equivalent on November 1, 2011. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Shenzhen Healthcare Electronic Technology Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2011
- Date Received
- October 4, 2011
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Body Composition
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- GU
- Submission Type