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FDA 510(k) Application Details - K042128
Device Classification Name
Stethoscope, Electronic
More FDA Info for this Device
510(K) Number
K042128
Device Name
Stethoscope, Electronic
Applicant
ZARGIS MEDICAL CORP.
755 COLLEGE RD. EAST
PRINCETON, NJ 08540 US
Other 510(k) Applications for this Company
Contact
DONALD BROOKS
Other 510(k) Applications for this Contact
Regulation Number
870.1875
More FDA Info for this Regulation Number
Classification Product Code
DQD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/06/2004
Decision Date
09/08/2004
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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