DeviceClearance

Product code NPP— Cardiovascular

HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF

Classification name
Reprocessed Blood Pressure Cuff
Device class
Class 2
Regulation
21 CFR 870.1120
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NPP under 21 CFR 870.1120, via openFDA

Market context for product code NPP

FDA has cleared 1 device under product code NPP, all in 2003, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NPP

Recent clearances under product code NPP

Data sourced from openFDA. This site is unofficial and independent of the FDA.