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510(k) K020060

ASTOFLO by Nats Corp. — Product Code BSB

K020060 is an FDA 510(k) premarket notification submitted by Nats Corp. for the device "ASTOFLO". The FDA issued a decision of Substantially Equivalent on March 5, 2002. The device falls under product code BSB (Warmer, Blood, Non-Electromagnetic Radiation), a Class II device regulated under 21 CFR 864.9205. Nats Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2002
Date Received
January 8, 2002
Clearance Type
Abbreviated
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 Nats Corp.

  • K040143 — MONORAIL (September 13, 2004)
  • K033142 — POWERED WHEELCHAIR (May 19, 2004)
  • K011820 — DENTORIUM CONVERTIBLE ACRYLIC (September 5, 2001)
  • K991184 — HYDROTONE-THERMAL CAPSULE SYSTEM (June 23, 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)
  • 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