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510(k) K110429

PROSIM 4, PROSIM 6, PROSIM 8 by Fluke Biomedical — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2011
Date Received
February 15, 2011
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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  • K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (December 24, 2008)
  • K072114 — IMPULSE 6000D/7000DP (January 28, 2008)

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