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FDA 510(k) Application Details - K002310
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K002310
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
MERIDIAN MEDICAL TECHNOLOGIES LTD.
207 AIRPORT RD., WEST
BELFAST BT3 9ED IE
Other 510(k) Applications for this Company
Contact
GERARD LYNN
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
07/31/2000
Decision Date
10/25/2000
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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