510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OACClass II

Plethysmograph, Air Displacement For Body Composition Analysis

21 CFR 870.2770 / Cardiovascular
FDA source (opens on fda.gov)

OAC is the FDA product code for Plethysmograph, Air Displacement For Body Composition Analysis, a class II device type, regulated under 21 CFR 870.2770. FDA's definition for this code reads: "To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass)". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OAC
Device name
Plethysmograph, Air Displacement For Body Composition Analysis
FDA definition
To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code OAC

By decision year
3 clearances under product code OAC with a decision year between 1995 and 2006, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OAC by decision year
YearClearances
19951
20041
20061

Applicants with the most clearances

Product code OAC
Applicants holding the most 510(k) clearances under product code OAC
ApplicantClearances
Life Measurement, Inc.2
Life Measurement Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code