510(k) K040978
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2004
- Date Received
- April 15, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Analyzer, Body Composition
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- GU
- Submission Type