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FDA 510(k) Application Details - K981378
Device Classification Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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510(K) Number
K981378
Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Applicant
DATEX-ENGSTROM, INC.
3 HIGHWOOD DR.
TEWKSBURY, MA 01876 US
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Contact
JOEL C KENT
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Regulation Number
870.2300
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Classification Product Code
DRT
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More FDA Info for this Product Code
Date Received
04/16/1998
Decision Date
11/03/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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