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FDA 510(k) Application Details - K993617
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
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510(K) Number
K993617
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
BRAEMAR CORP.
11481 RUPP DR.
BURNSVILLE, MN 55337 US
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Contact
DAVID NORBERG
Other 510(k) Applications for this Contact
Regulation Number
870.2800
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Classification Product Code
MWJ
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More FDA Info for this Product Code
Date Received
10/26/1999
Decision Date
11/24/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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