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FDA 510(k) Application Details - K982104
Device Classification Name
Monitor, St Segment With Alarm
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510(K) Number
K982104
Device Name
Monitor, St Segment With Alarm
Applicant
MEDICAL DATA ELECTRONICS
12720 WENTWORTH ST.
ARLETA, CA 91331 US
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Contact
DAVID M TRUEBLOOD
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Regulation Number
870.1025
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Classification Product Code
MLD
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More FDA Info for this Product Code
Date Received
06/15/1998
Decision Date
11/25/1998
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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