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FDA PRODUCT CODE · CLASS II

QJG — Device System, Imaging, Tympanic Membrane And Middle Ear

Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.

DEVICE CLASS
Class II
REGULATION
21 CFR 892.1560
MEDICAL SPECIALTY
Radiology
REVIEW PANEL
EN
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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