510(k) K032821
K032821 is an FDA 510(k) premarket notification submitted by Hygia Health Services, Inc. for the device "HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF". The FDA issued a decision of Substantially Equivalent on December 5, 2003. The device falls under product code NPP (Reprocessed Blood Pressure Cuff), a Class II device regulated under 21 CFR 870.1120. Hygia Health Services, Inc. has at least 10 other 510(k) clearances on record.
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.