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FDA 510(k) Application Details - K981394
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
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510(K) Number
K981394
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
BRAEMAR CORP.
11481 RUPP DR.
BURNSVILLE, MN 55337 US
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DAVID NORBERG
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Regulation Number
870.2920
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Classification Product Code
DXH
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More FDA Info for this Product Code
Date Received
04/17/1998
Decision Date
09/28/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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