Reprocessed Blood Pressure Cuff

Device Code: 917

Product Code(s): NPP

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 Ma

Device Classification Information

Device Type ID917
Device NameReprocessed Blood Pressure Cuff
Regulation DescriptionBlood Pressure Cuff.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type510(k)
CFR Regulation Number870.1120 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNPP
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID917
DeviceReprocessed Blood Pressure Cuff
Product CodeNPP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionBlood Pressure Cuff.
CFR Regulation Number870.1120 [🔎]
TPLC Last Update: 2019-04-02 19:44:51

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