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510(k) K830165

Device
BEAR JET 150 VENTILATOR
Applicant
BEAR MEDICAL SYSTEMS, INC.
510(k) number
K830165
Product code
FLI  
Decision
Substantially Equivalent (SESE)
Decision date
1983-04-12
Date received
1983-01-18
Regulation
880.6100
Classification name
Cabinet, Ethylene-oxide Gas Aerator
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FLI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904921STERI-VAC(TM) AERATOR MODEL XL3M Health Care, Ltd.1990-12-05
K902906GAS-VAK(R) COMBINATION STERILIZER & VENTILATORGas-Vak1990-10-15
K831595CASTLE MODEL 3341 & 3441 & 4141 GAS AERCastle Co.1983-06-15
K813201CASTLE #3241 GAS AERATORSybron Corp.1981-12-31
K790677EO EVACUATING SYSTEM ICastle Co.1979-05-07
K781484CASTLE MODEL 3146 GAS AERATORCastle Co.1978-10-27
K761341PORTAGAS AERATORAmsco Co.1977-02-28

Legacy Summary#

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FDA Review#

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