510(k) K100183
K100183 is an FDA 510(k) premarket notification submitted by Tanita Corp. for the device "MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER". The FDA issued a decision of Substantially Equivalent on Apr 15, 2011. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 15, 2011
- Date Received
- Jan 21, 2010
- 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
- 510(k)