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510(k) K854924

AMI E-Z-PACE ELECTODE by A.M.I. Corp. — Product Code DRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1986
Date Received
December 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device Class
Class II
Regulation Number
870.5550
Review Panel
CV
Submission Type

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