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510(k) K860636

FASTRACE III, ECG ELECTRODE by Andover Medical, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1986
Date Received
February 21, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
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)
  • 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)
  • K843409 — FLOW-DIRECTED THERMODILUTION CATH (October 18, 1984)

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