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510(k) K853040

Device
PRESSURE GAUGE
Applicant
ERIE MEDICAL
510(k) number
K853040
Product code
BXH  
Decision
Substantially Equivalent (SESE)
Decision date
1985-10-10
Date received
1985-07-19
Regulation
868.2610
Classification name
Gauge, Gas Pressure, Cylinder/pipeline
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
STEVEN A CASE
Address
4000 S. 13th St. Milwaukee WI US 53221 53221

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
K942645B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REGB & F Medical Products, Inc.1994-07-27
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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