FDA 510(k) Application Details - K000221

Device Classification Name

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510(K) Number K000221
Device Name SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
Applicant GE DEC MEDICAL SYSTEMS
384 WRIGHT BROTHERS DR.
SALT LAKE CITY, UT 84116 US
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Contact TED L PARROT
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Regulation Number

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Classification Product Code OWB
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Date Received 01/24/2000
Decision Date 04/11/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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