Atlas FDA

NPP

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
Reprocessed Blood Pressure Cuff
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1120
Medical specialty
Cardiovascular
Flags
Third-party review eligible
FDA definition
The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual bp measurement.
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RecordFirmDateBuilder
HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF (K032821)Hygia Health Services, Inc.2003-12-05+ Add

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