Set, Anesthesia, Obstetric

Device Code: 3997

Product Code(s): KNE

Device Classification Information

Device Type ID3997
Device NameSet, Anesthesia, Obstetric
Regulation DescriptionObstetric Anesthesia Set.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission Type510(k)
CFR Regulation Number884.5100 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKNE
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 ID3997
DeviceSet, Anesthesia, Obstetric
Product CodeKNE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric Anesthesia Set.
CFR Regulation Number884.5100 [🔎]
TPLC Last Update: 2019-04-02 20:41:25

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