Flowmeter, Nonback-pressure Compensated, Bourdon Gauge

Device Code: 117

Product Code(s): CCN

Device Classification Information

Device Type ID117
Device NameFlowmeter, Nonback-pressure Compensated, Bourdon Gauge
Regulation DescriptionBourdon Gauge Flowmeter.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type510(K) Exempt
CFR Regulation Number868.2300 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeCCN
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID117
DeviceFlowmeter, Nonback-pressure Compensated, Bourdon Gauge
Product CodeCCN
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionBourdon Gauge Flowmeter.
CFR Regulation Number868.2300 [🔎]
TPLC Last Update: 2019-04-02 19:29:17

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