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510(k) K112639

THE BELMONT BUDDY LITE FLUID WARMER by Belmont Instrument Corp. — Product Code BSB

K112639 is an FDA 510(k) premarket notification submitted by Belmont Instrument Corp. for the device "THE BELMONT BUDDY LITE FLUID WARMER". The FDA issued a decision of Substantially Equivalent on November 16, 2011. The device falls under product code BSB (Warmer, Blood, Non-Electromagnetic Radiation), a Class II device regulated under 21 CFR 864.9205. Belmont Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2011
Date Received
September 12, 2011
Clearance Type
Special
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 Belmont Instrument Corp.

  • K131519 — BELMONT HYPERTHERMIA PUMP (November 6, 2013)
  • K091855 — THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 (July 1, 2009)
  • K090508 — THE BELMONT BUDDY LITE FLUID WARMER (March 26, 2009)
  • K090089 — BELMONT HYPERTHERMIA PUMP (February 12, 2009)
  • K070654 — HYPERTHERMIA PUMP (June 8, 2007)
  • K062774 — BELMONT BUDDY PLUS FLUID WARMER (October 19, 2006)
  • K052547 — BELMONT BUDDY FLUID WARMER (October 13, 2005)
  • K032778 — LARGE VOLUME FLUID RESERVOIR (September 22, 2003)
  • K032674 — BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 (September 16, 2003)
  • K031478 — MICROHEATER (July 2, 2003)

Other clearances for product code BSB

  • 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)
  • K973741 — BAIR HUGGER BLOOD/FLUID WARMER (April 30, 1998)

FDA data resources