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510(k) K791645

VICKERS MEDICAL MODEL 112 TREONIC DC2 by Vickers America Medical Corp. — Product Code FKW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1979
Date Received
August 23, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tip, Vessel
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Other clearances by Vickers America Medical Corp.

  • K840823 — TREONIC C30 (March 23, 1984)
  • K831838 — LABORATORY DATA MGMT SYSTEM SDMS (January 24, 1984)
  • K830748 — RESUSCITAIRE (June 22, 1983)
  • K830936 — TREONIC IP5 (April 12, 1983)
  • K813239 — OXYGENAIRE NURING INCUBATOR (January 28, 1982)
  • K813238 — NEOCARE BABY-CONTROLLED INCUBATOR (January 22, 1982)
  • K811865 — VMA PEDIATRIC APNEA MATTRESS (July 31, 1981)
  • K810792 — NEOCARE TEMPERATURE MONITOR (April 29, 1981)
  • K810571 — NEOCARE OXYGEN MONITOR (March 11, 1981)
  • K810067 — 140 NEOCARE AIR CONTROLLED INCUBATOR (March 11, 1981)

Other clearances for product code FKW

  • K893438 — T SERIES VESSEL TIPS (June 8, 1989)
  • K810257 — VESSEL TIPS, SIZES 13-18 (March 13, 1981)