510(k) K032821

HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF by Hygia Health Services, Inc. — Product Code NPP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 5, 2003
Date Received: September 5, 2003
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Reprocessed Blood Pressure Cuff
Device Class: Class II
Regulation Number: 870.1120
Review Panel: CV
Submission Type

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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