FDA 510(k) Application Details - K032252

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K032252
Device Name System, Monitoring, Perinatal
Applicant GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4502 WOODLAND CORPORATE BLVD.
TAMPA, FL 33614 US
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Contact MELISSA ROBINSON
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 07/22/2003
Decision Date 08/21/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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