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510(k) K770232

BLOOD/FLUID WARMER MODEL DW-1000A by Gorman Rupp Industries — Product Code BSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1977
Date Received
February 7, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Blood, Non-Electromagnetic Radiation
Device Class
Class II
Regulation Number
864.9205
Review Panel
HE
Submission Type

Other clearances by Gorman Rupp Industries

  • K771537 — AQUAMATIC K-MODULE MODEL K-20 (September 6, 1977)
  • K770839 — AQUAMATIC K-77 (June 8, 1977)
  • K761337 — AQUAMATIC K-MODULE MODEL K-10 (January 10, 1977)
  • K760910 — DISPOSABLE K-PADS (December 16, 1976)
  • K761087 — ELECTRONIC CONTROL UNIT (December 6, 1976)

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  • K020060 — ASTOFLO (March 5, 2002)
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  • K984640 — THERMAL ANGEL (July 1, 1999)