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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gas-machine, anesthesia
510(k) Number K971030
Device Name MIE FALCON, DATEX ENGSTROM FLEXIMA II
Applicant
MEDICAL AND INDUSTRIAL EQUIPMENT
FALCON RD SOWTON INDUSTRIAL
ESTATE
EX2 7NA EXETER,  GB
Applicant Contact HENRY MARSHALL
Correspondent
MEDICAL AND INDUSTRIAL EQUIPMENT
FALCON RD SOWTON INDUSTRIAL
ESTATE
EX2 7NA EXETER,  GB
Correspondent Contact HENRY MARSHALL
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received03/20/1997
Decision Date 11/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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