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BZO — Set, Tubing And Support, Ventilator (W Harness) Class I

FDA Device Classification

Classification Details

Product Code
BZO
Device Class
Class I
Regulation Number
868.5975
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K953784unicorUNICOR, INC. CORRUGATED TUBINGSeptember 19, 1995
K953785unicorUNICOR, INC. VENTILATOR HOSESSeptember 18, 1995
K952022primaPRIMA VOLUMN VENTILATORSSMay 22, 1995
K952012primaPRIMA CUSTOM ANESTESIA CIRCUITMay 22, 1995
K952011primaPRIMA BREATHING BAGSMay 22, 1995
K952010primaPRIMA VENTILATOR HOSESMay 22, 1995
K945740hamilton medicalINFANT FLOW SYSTEMMarch 23, 1995
K944531primaPRIMA, INC. CORRUGATED TUBINGDecember 2, 1994
K942569med-plastics intlVENTILATOR HOSEJune 10, 1994
K942572med-plastics intlVOLUME VENTILATORJune 10, 1994
K935582puritas health careTUBE, INHALER OXYGENJanuary 14, 1994
K934753infrasonicsSTAR BREATHING CIRCUITSOctober 27, 1993
K932706precision med productsPRECISION MED PRODUCTS LTD. VENTILATOR HOSEJuly 23, 1993
K932560life shield healthcare productsVOLUME VENTILATORSJuly 22, 1993
K932712precision med productsPRECISION MED PRODUCTS LTD VOLUME VENTILATORSJuly 22, 1993
K932563life shield healthcare productsVENTILATOR HOSESJuly 16, 1993
K932119cleveland tubingCLEVELAND TUBING, INC. VENTILATOR HOSESJune 23, 1993
K922479intertech resourcesDISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIEDOctober 30, 1992
K921510respiratory support productsGAS SAMPLING KIT MODIFICATIONJune 11, 1992
K911328intertech resourcesUNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATIONAugust 15, 1991