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BTC — Bag, Reservoir Class I

FDA Device Classification

Classification Details

Product Code
BTC
Device Class
Class I
Regulation Number
868.5320
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K181424pediaPeDIASeptember 25, 2018
K940220zefon medical productsREBREATHER BAGSMay 27, 1994
K932581med-plastics intlBREATHING BAGSJuly 16, 1993
K932496precision med productsPRECISION MED PRODUCTS, LTD. BREATHING BAGSJuly 16, 1993
K932584merit medical systemsBREATHING BAGSJuly 16, 1993
K932191life shield healthcare productsBREATHING BAGSJuly 2, 1993
K894906med-tekANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITERSeptember 18, 1989
K880680king systemsKING SYSTEMS, BREATHING BAGMarch 3, 1988
K864822surgidyneVARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYSJanuary 15, 1987
K841412warne surgical productsROLLED NECK W/TAPApril 18, 1984
K841411warne surgical productsROLLED NECK W/PLUGApril 18, 1984
K830399khiCOUPLING/VALVEMarch 10, 1983
K830056artec environmental monitoring divisionARTEC TWIST VALVEMarch 9, 1983
K822216quest medicalVOLUMETRIC CONTROLLERAugust 16, 1982
K822116life design systemsANESTHESIA BREATHING BAG, VARIOUS SIZESAugust 16, 1982
K821309esp plasticsESPREE', BREATHING BAGMay 21, 1982
K800155drydenDISPOSAL LITER BREATHING BAGFebruary 21, 1980
K791910mem medicalTHREE LITER BAG #M-512October 9, 1979
K791463cameron medicalPARA-VENTSeptember 17, 1979