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FDA 510(k) Application Details - K003672
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device
510(K) Number
K003672
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
MEDGE PLATFORMS, INC.
90 PARK AVE.
17TH FLOOR
NEW YORK, NY 10016-1301 US
Other 510(k) Applications for this Company
Contact
GUSTAVO EDUARDO ABELLA
Other 510(k) Applications for this Contact
Regulation Number
892.1560
More FDA Info for this Regulation Number
Classification Product Code
IYO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/28/2000
Decision Date
02/22/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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