510(k) K010706
K010706 is an FDA 510(k) premarket notification submitted by Measurement Specialties, Inc. for the device "THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER". The FDA issued a decision of Substantially Equivalent on October 5, 2001. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Measurement Specialties, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 2001
- Date Received
- March 9, 2001
- Clearance Type
- Traditional
- 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