510(k) K032610
K032610 is an FDA 510(k) premarket notification submitted by Life Measurement, Inc. for the device "MODIFIED SONAMET BODY COMPOSITION ANALYZER". The FDA issued a decision of Substantially Equivalent on March 1, 2004. The device falls under product code OAC (Plethysmograph, Air Displacement For Body Composition Analysis), a Class II device regulated under 21 CFR 870.2770. Life Measurement, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2004
- Date Received
- August 25, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Air Displacement For Body Composition Analysis
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- OB
- Submission Type
To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).