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510(k) K812878

THE NEW 1600 ELECTRODE by Andover Medical, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1981
Date Received
October 14, 1981
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 Andover Medical, Inc.

  • K905729 — CANMED 451 (February 7, 1991)
  • K903427 — NORTECH MODEL 86901000 ELECTRODE (August 17, 1990)
  • K885171 — MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE (January 12, 1989)
  • K860636 — FASTRACE III, ECG ELECTRODE (May 9, 1986)
  • K854433 — ECG MONITORING/DEFIBRILLATION ELECTRODE (May 8, 1986)
  • K860535 — UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) (April 1, 1986)
  • K860283 — AMI CARDIO-PAD (March 31, 1986)
  • K843412 — FLOW DIRECTED THERMODILUTION CATH W/VEN (November 20, 1984)
  • K843410 — FLOW-DIRECTED PEDIATRIC THERMODIL- CATH (November 20, 1984)
  • K843411 — THERMAL DILUTION CATHETER (October 18, 1984)

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  • K101685 — IP-SET (July 1, 2010)
  • K100129 — AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (June 11, 2010)
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  • K100315 — 12 LEAD GLOVE (April 23, 2010)
  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (December 10, 2009)
  • K092389 — DISPOSAL ECG ELECTRODES, MODEL EASYRODE (October 13, 2009)