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510(k) K860535

UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) by Andover Medical, Inc. — Product Code CAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1986
Date Received
February 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Nasal, Oxygen
Device Class
Class I
Regulation Number
868.5340
Review Panel
AN
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)
  • 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)

Other clearances for product code CAT

  • K011125 — NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA M (June 13, 2001)
  • K935533 — NASAL CANNULA (February 3, 1994)
  • K922397 — 4 SURE TM NASAL OXYGEN CANNULA (March 18, 1993)
  • K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED (August 14, 1992)
  • K920573 — CANNULA NASAL OXYGEN (August 11, 1992)
  • K913421 — NASAL OXYGEN CANNULA, 81585, 81587 & 81589 (October 18, 1991)
  • K912197 — SKIN SAVER(TM) TUBING HOLDER, MODEL 467 (August 20, 1991)
  • K911740 — SALTER LABS NEONATAL NASAL OXYGEN CANNULA (July 24, 1991)
  • K902420 — CATHETER, NASAL, OXYGEN (April 17, 1991)
  • K896036 — THE COMFORTABLE CANNULA (November 17, 1989)