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510(k) K770232

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

K770232 is an FDA 510(k) premarket notification submitted by Gorman Rupp Industries for the device "BLOOD/FLUID WARMER MODEL DW-1000A". The FDA issued a decision of Substantially Equivalent on February 14, 1977. The device falls under product code BSB (Warmer, Blood, Non-Electromagnetic Radiation), a Class II device regulated under 21 CFR 864.9205. Gorman Rupp Industries has at least 5 other 510(k) clearances on record.

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)

Other clearances for product code BSB

  • K112639 — THE BELMONT BUDDY LITE FLUID WARMER (November 16, 2011)
  • K090508 — THE BELMONT BUDDY LITE FLUID WARMER (March 26, 2009)
  • K062774 — BELMONT BUDDY PLUS FLUID WARMER (October 19, 2006)
  • K052547 — BELMONT BUDDY FLUID WARMER (October 13, 2005)
  • K031478 — MICROHEATER (July 2, 2003)
  • K020060 — ASTOFLO (March 5, 2002)
  • K012031 — MODIFICATION TO THERMAL ANGEL (July 26, 2001)
  • K991159 — PRISMATHERM II, ASTOLINE (September 3, 1999)
  • K991160 — ASTOTHERM PLUS, ASTOTUBES, ASTOLINE (September 2, 1999)
  • K984640 — THERMAL ANGEL (July 1, 1999)

FDA data resources