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FDA 510(k) Application Details - K170181
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K170181
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
G-Medical Innovations Ltd.
5 Openheimer St., Park Rabin
Rehovot 7670105 IL
Other 510(k) Applications for this Company
Contact
N. Epstein
Other 510(k) Applications for this Contact
Regulation Number
870.2920
More FDA Info for this Regulation Number
Classification Product Code
DXH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/19/2017
Decision Date
09/01/2017
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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