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FDA 510(k) Application Details - K973437
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K973437
Device Name
Electrocardiograph
Applicant
HEWLETT-PACKARD GMBH
SCHICKARD STRASSE 4
BOEBLINGEN
WUERTTEMBERG 71034 DE
Other 510(k) Applications for this Company
Contact
EGON PFEIL
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/10/1997
Decision Date
12/03/1997
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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