510(k) K140045
K140045 is an FDA 510(k) premarket notification submitted by Jawon Medical Co., Ltd. for the device "BODY COMPOSITION ANALYZER". The FDA issued a decision of Substantially Equivalent on February 18, 2015. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Jawon Medical Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2015
- Date Received
- January 8, 2014
- 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