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FDA 510(k) Application Details - K971650
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
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510(K) Number
K971650
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
DATA CRITICAL CORP.
9223 ILONA LN.
HOUSTON, TX 77025-4218 US
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Contact
LISA S JONES
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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
05/06/1997
Decision Date
12/04/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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