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FDA 510(k) Application Details - K052412
Device Classification Name
More FDA Info for this Device
510(K) Number
K052412
Device Name
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
Applicant
GE HEALTHCARE
3000 N. GRANDVIEW BLVD
WAUKESHA, WI 53188 US
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Contact
LARRY A KROGER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/02/2005
Decision Date
09/16/2005
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
Y
Expedited Review
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