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510(k) K103336

MPS450 MULTIPARAMETER SIMULATOR by Fluke Biomedical — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2011
Date Received
November 15, 2010
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

Other clearances by Fluke Biomedical

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  • K121722 — ESA620 ELECTRICAL SAFETY ANALYZER (October 11, 2012)
  • K110429 — PROSIM 4, PROSIM 6, PROSIM 8 (September 2, 2011)
  • K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (December 24, 2008)
  • K072114 — IMPULSE 6000D/7000DP (January 28, 2008)

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