Table, Obstetric (and Accessories)

Device Code: 3995

Product Code(s): KNC

Device Classification Information

Device Type ID3995
Device NameTable, Obstetric (and Accessories)
Regulation DescriptionObstetric Table And Accessories.
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) Exempt
CFR Regulation Number884.4900 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKNC
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 ID3995
DeviceTable, Obstetric (and Accessories)
Product CodeKNC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionObstetric Table And Accessories.
CFR Regulation Number884.4900 [🔎]
Recalls
Manufacturer Recall Class Date Posted
1
Hill-Rom, Inc.
II Sep-08-2016
2
Hill-Rom, Inc.
II Sep-01-2014
TPLC Last Update: 2019-04-02 20:41:23

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