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510(k) K121722

ESA620 ELECTRICAL SAFETY ANALYZER by Fluke Biomedical — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2012
Date Received
June 12, 2012
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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  • K083347 — IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS (December 24, 2008)
  • K072114 — IMPULSE 6000D/7000DP (January 28, 2008)

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