510(k) K122388
K122388 is an FDA 510(k) premarket notification submitted by Seca GmbH & Co. KG for the device "SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514". The FDA issued a decision of Substantially Equivalent on May 2, 2013. The device falls under product code MNW (Analyzer, Body Composition), a Class II device regulated under 21 CFR 870.2770. Seca GmbH & Co. KG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2013
- Date Received
- August 6, 2012
- 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