← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · UNCLASSIFIED

QNZPowered Communication System For Emergency Use

Powered environmental control system to support remote nurse call events, including those originating from ventilators, by trained health care providers from outside an isolation unit to avoid unnecessary exposures during the declared public health emergency.

DEVICE CLASS
Unclassified
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
ImplantLife-sustainingGMP-exemptThird-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA 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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