FDA 510(k) Application Details - K822316

Device Classification Name Monitor, Line Isolation

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510(K) Number K822316
Device Name Monitor, Line Isolation
Applicant HMBA

, US
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Regulation Number 870.2620

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Classification Product Code DRI
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Date Received 08/03/1982
Decision Date 09/21/1982
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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