Transducer, Miniature Pressure

Device Code: 5060

Product Code(s): IKE

Device Classification Information

Device Type ID5060
Device NameTransducer, Miniature Pressure
Regulation DescriptionMiniature Pressure Transducer.
Regulation Medical SpecialtyPhysical Medicine
Review PanelPhysical Medicine
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type510(K) Exempt
CFR Regulation Number890.1615 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIKE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5060
DeviceTransducer, Miniature Pressure
Product CodeIKE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMiniature Pressure Transducer.
CFR Regulation Number890.1615 [🔎]
TPLC Last Update: 2019-04-02 20:59:33

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