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510(k) K942645

Device
B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
Applicant
B & F MEDICAL PRODUCTS, INC.
510(k) number
K942645
Product code
BXH  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-27
Date received
1994-06-03
Regulation
868.2610
Classification name
Gauge, Gas Pressure, Cylinder/pipeline
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ILENE KNABLE GOTTS
Address
Washington Harbour 3000 K St., NW Suite 500 Washington DC US 20007 20007

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BXH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K853040PRESSURE GAUGEErie Medical1985-10-10
K843212LOW PRESSURE ALARM FOR OXYGEN CYLINDERHospitak, Inc.1984-09-19
K770614MONITOR, GAS MANIFOLDDynatech Cryomedical Co.1977-04-07

Legacy Summary#

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FDA Review#

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