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510(k) K984640

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

K984640 is an FDA 510(k) premarket notification submitted by Estill Medical Technologies, Inc. for the device "THERMAL ANGEL". The FDA issued a decision of Substantially Equivalent on July 1, 1999. 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 1, 1999
Date Received
December 31, 1998
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 Estill Medical Technologies, Inc.

  • K012031 — MODIFICATION TO THERMAL ANGEL (July 26, 2001)

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

FDA data resources