Home / 510(k) Clearances / K790936

510(k) K790936

MODEL 114 TREONIC H150 HAEMOHEATER by Vickers America Medical Corp. — Product Code KZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 4, 1979
Date Received
May 18, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Warming. Blood And Plasma
Device Class
Class II
Regulation Number
864.9205
Review Panel
HE
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 KZL

  • K813489 — ROCKING/CIRCULATING CYTO-THERM II 3570 (March 4, 1982)
  • K812311 — CIRCULATING CYTO-THERMS (September 16, 1981)
  • K800699 — FLO TEM (FLUID WARNER) (May 8, 1980)