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510(k) K903939

Device
PANDA HELIUM GAS ANALYZER
Applicant
MEDICAL ASSOCIATED SERVICES, INC.
510(k) number
K903939
Product code
BSE  
Decision
Substantially Equivalent (SESE)
Decision date
1991-01-03
Date received
1990-08-27
Regulation
868.1640
Classification name
Analyzer, Gas, Helium, Gaseous-phase
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MARK S ALSBERGE
Address
P.O. Box 530 Hatfield PA US 19440 19440

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BSE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843843HE TESTErich Jaeger, Inc.1984-12-04
K841858SPIROLOOPDatamed, Inc.1984-07-11

Legacy Summary#

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FDA Review#

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