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510(k) K012031

MODIFICATION TO THERMAL ANGEL by Estill Medical Technologies, Inc. — Product Code BSB

K012031 is an FDA 510(k) premarket notification submitted by Estill Medical Technologies, Inc. for the device "MODIFICATION TO THERMAL ANGEL". The FDA issued a decision of Substantially Equivalent on July 26, 2001. The device falls under product code BSB (Warmer, Blood, Non-Electromagnetic Radiation), a Class II device regulated under 21 CFR 864.9205. Estill Medical Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2001
Date Received
June 28, 2001
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 Estill Medical Technologies, Inc.

  • K984640 — THERMAL ANGEL (July 1, 1999)

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)
  • 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