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510(k) K971030

MIE FALCON, DATEX ENGSTROM FLEXIMA II by Medical and Industrial Equipment — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1997
Date Received
March 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type

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