← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
OAC — Plethysmograph, Air Displacement For Body Composition Analysis
To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).
DEVICE CLASS
Class II
REGULATION
21 CFR 870.2770
MEDICAL SPECIALTY
Cardiovascular
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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