FDA.reportPublic FDA data

510(k) K951652

Device
VENTIMASK MK IV
Applicant
FLEXICARE MEDICAL LTD.
510(k) number
K951652
Product code
BYF  
Decision
Substantially Equivalent (SESE)
Decision date
1995-04-27
Date received
1995-04-10
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
COLIN BECKETT
Address
East Quay, Bridgwater Somerset GB TA64DB TA64DB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BYF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955483TRACH MASK MODEL (245, 246)Hospitak, Inc.1996-02-28
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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases