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FDA 510(k) Application Details - K962699
Device Classification Name
System, Digital Image Communications, Radiological
More FDA Info for this Device
510(K) Number
K962699
Device Name
System, Digital Image Communications, Radiological
Applicant
APPLICARE MEDICAL IMAGING, B.V.
12300 TWINBROOK PKWY.
SUITE 625
ROCKVILLE, MD 20852 US
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Contact
ROBERT L SHERIDAN
Other 510(k) Applications for this Contact
Regulation Number
892.2020
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Classification Product Code
LMD
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More FDA Info for this Product Code
Date Received
07/11/1996
Decision Date
08/19/1996
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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