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510(k) K800699

FLO TEM (FLUID WARNER) by Chroma Products, Inc. — Product Code KZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
March 28, 1980
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 for product code KZL

  • K813489 — ROCKING/CIRCULATING CYTO-THERM II 3570 (March 4, 1982)
  • K812311 — CIRCULATING CYTO-THERMS (September 16, 1981)
  • K790936 — MODEL 114 TREONIC H150 HAEMOHEATER (September 4, 1979)