Oscillometer

Device Code: 763

Product Code(s): DRZ

Device Classification Information

Device Type ID763
Device NameOscillometer
Regulation DescriptionOscillometer.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type510(K) Exempt
CFR Regulation Number870.2675 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDRZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID763
DeviceOscillometer
Product CodeDRZ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionOscillometer.
CFR Regulation Number870.2675 [🔎]
TPLC Last Update: 2019-04-02 19:40:49

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