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FDA 510(k) Application Details - K981066
Device Classification Name
System, Ecg Analysis
More FDA Info for this Device
510(K) Number
K981066
Device Name
System, Ecg Analysis
Applicant
FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND, WA 98052-4911 US
Other 510(k) Applications for this Company
Contact
DAVID J GERAGHTY
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LOS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/24/1998
Decision Date
08/31/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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