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510(k) K955483

Device
TRACH MASK MODEL (245, 246)
Applicant
HOSPITAK, INC.
510(k) number
K955483
Product code
BYF  
Decision
Substantially Equivalent (SESE)
Decision date
1996-02-28
Date received
1995-12-01
Regulation
868.5600
Classification name
Mask, Oxygen, Low Concentration, Venturi
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM LACEY
Address
10 Daniel St. Farmingdale NY US 11735 11735

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code BYF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951652VENTIMASK MK IVFlexicare Medical, Ltd.1995-04-27
K894457CARNATION TRACHEOSTOMY MASKSDadsun Corp., Ltd.1989-10-13
K860873VENTURI MASK/ADULT & PAEDIATRICDhd Medical Products Div. Diemolding Corp.1986-03-20
K860874VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRICDhd Medical Products Div. Diemolding Corp.1986-03-19
K852618OXY-DIALAshai Co. , Ltd.1985-09-18
K832725DUAL DIAL VENTURI STYLE MASKAirlife, Inc.1983-09-20
K812066PERCENTO MASK, PEDIATRIC, UNDER-THE-CHINAirlife, Inc.1981-08-03
K810946ADULT & PEDIATRIC TRACHEOSTOMY MASKSAirlife, Inc.1981-06-02
K810947AIR ENTRAINMENT TRACH TAirlife, Inc.1981-06-02
K810373VENTURI MASK/DELIVERY SYSTEM #'STodd Industries, Inc.1981-03-17
K810430VENTURI MASK/DELIVERY SYSTEM #6078Todd Industries, Inc.1981-03-13
K790146MASK, PERCENTOAirlife, Inc.1979-02-06
K781325MARKII VENTIMASKSVickers America Medical Corp.1978-09-27
K780626VENTURI OXYGEN MASKHospitak, Inc.1978-05-26
K780011CONCHAPAK OXYGEN DILUTERRespiratory Care, Inc.1978-02-02

Legacy Summary#

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FDA Review#

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