510(k) K060848

Device: BOD POD
Applicant: LIFE MEASUREMENT, INC.
510(k) number: K060848
Product code: OAC
Decision: Substantially Equivalent (SESE)
Decision date: 2006-06-27
Date received: 2006-03-28
Regulation: 870.2770
Classification name: Plethysmograph, Air Displacement For Body Composition Analysis
Medical specialty: Cardiovascular
Review panel: Obstetrics/Gynecology
Device class: 2
Clearance type: Abbreviated
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MICHAEL SULLIVAN
Address: 1850 Bates Ave. Concord CA US 94520 94520

FDA Registration Numbers#

3003873943

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00866203000236	BOD POD® GS-X Body Composition System	COSMED USA, INC.	2020-10-20
00866203000212	BOD POD® Body Composition System	COSMED USA, INC.	2016-09-21
00866203000205	BOD POD® Body Composition System	COSMED USA, INC.	2016-09-21

Other 510(k) Records For Product Code OAC #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K032610	MODIFIED SONAMET BODY COMPOSITION ANALYZER	Life Measurement, Inc.	2004-03-01
K924972	SONAMET BODY COMPOSITION ANALYZER	Life Measurement Instruments, Inc.	1995-02-13

Legacy Summary#

summary

FDA Review#

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