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FDA 510(k) Application Details - K992305
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K992305
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
MEDI-STIM A/S
PO BOX 35 GREFSEN,N-0409 OSLO
SANDAKERVEIEN 110
OSLO N-0475 NO
Other 510(k) Applications for this Company
Contact
JON H HOEM
Other 510(k) Applications for this Contact
Regulation Number
892.1570
More FDA Info for this Regulation Number
Classification Product Code
ITX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/08/1999
Decision Date
09/08/1999
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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