FDA 510(k) Application Details - K871971

Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

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510(K) Number K871971
Device Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Applicant CARDIAC RESUCITATOR CORP.
12244 S.W. GARDEN PLACE
PORTLAND, OR US
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Contact JOHN L KARPOWICZ
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Regulation Number 870.5550

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Classification Product Code DRO
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Date Received 05/21/1987
Decision Date 06/24/1987
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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