Sonamet Body Composition Analyzer

FDA 510(k) K924972 · Life Measurement Instruments, Inc.

Substantially Equivalent

510(k) numberK924972

Submission

Device name
Sonamet Body Composition Analyzer
Applicant
Life Measurement Instruments, Inc.
Davis, CA, US
Received
September 30, 1992
Decision date
February 13, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K032610Modified Sonamet Body Composition AnalyzerOAC · Abbreviated Life Measurement, Inc.03/01/2004SE

Questions and answers

When was Sonamet Body Composition Analyzer cleared by the FDA?

Sonamet Body Composition Analyzer (K924972) received a 510(k) decision of Substantially Equivalent on February 13, 1995, 866 days after the submission was received.

What is the product code of K924972?

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.