FDA 510(k) Application Details - K022482

Device Classification Name Blood Pressure Cuff

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510(K) Number K022482
Device Name Blood Pressure Cuff
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 870.1120

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Classification Product Code DXQ
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Date Received 07/29/2002
Decision Date 08/13/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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