Modified Sonamet Body Composition Analyzer

FDA 510(k) K032610 · Life Measurement, Inc.

Substantially Equivalent

510(k) numberK032610

Submission

Device name
Modified Sonamet Body Composition Analyzer
Applicant
Life Measurement, Inc.
Los Altos, CA, US
Received
August 25, 2003
Decision date
March 1, 2004
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAC – Plethysmograph, Air Displacement For Body Composition Analysis
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2770
Specialty
Cardiovascular

To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).

Other 510(k)s with product code OAC

510(k)DeviceApplicantDecision
K060848Bod PodOAC · Abbreviated Life Measurement, Inc.06/27/2006SE
K924972Sonamet Body Composition AnalyzerOAC · Traditional Life Measurement Instruments, Inc.02/13/1995SE

More from Life Measurement Instruments, Inc.

510(k)DeviceDecision
K060848Bod PodOAC · Abbreviated 06/27/2006SE

Questions and answers

When was Modified Sonamet Body Composition Analyzer cleared by the FDA?

Modified Sonamet Body Composition Analyzer (K032610) received a 510(k) decision of Substantially Equivalent on March 1, 2004, 189 days after the submission was received.

What is the product code of K032610?

The FDA product code is OAC – Plethysmograph, Air Displacement For Body Composition Analysis, a Class II (moderate risk) device regulated under 21 CFR 870.2770.