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510(k) K822798

DISPOSABLE ELECTRODE #1900 by Andover Medical, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1982
Date Received
September 16, 1982
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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