FDA 510(k) Application Details - K837329

Device Classification Name

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510(K) Number K837329
Device Name SONACOLOR CD, MODEL 6300 CARDIAC DOPPLER ULTRASOUND
Applicant CAROLINA MEDICAL ELECTRONICS
P. O. BOX 307
KING, NC US
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Regulation Number

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Classification Product Code
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Date Received 03/08/1983
Decision Date 06/07/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee RA - Radiology
Review Advisory Committee -
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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