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510(k) K961288

BODYTRODE by Marquette Electronics, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 1996
Date Received
April 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

Other clearances by Marquette Electronics, Inc.

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  • K972199 — SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSIS (September 25, 1997)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K962827 — ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) (February 24, 1997)
  • K964750 — EAGLE 4000 PATIENT MONITOR (February 21, 1997)
  • K962551 — CARDIOSERV S (November 19, 1996)
  • K960272 — EAGLE 3000/3100 PATIENT MONITOR (October 2, 1996)
  • K960418 — EAGLE PATIENT MONITOR (October 2, 1996)

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  • K100315 — 12 LEAD GLOVE (April 23, 2010)
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  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)