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510(k) K853953

CARDIOCAP MONITOR by Instrumentarium Corp. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1986
Date Received
September 25, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

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