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510(k) K042145

READY-HEAT BLANKET by Techtrade, LLC — Product Code KME

K042145 is an FDA 510(k) premarket notification submitted by Techtrade, LLC for the device "READY-HEAT BLANKET". The FDA issued a decision of Substantially Equivalent on September 17, 2004. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. Techtrade, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2004
Date Received
August 9, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bedding, Disposable, Medical
Device Class
Class I
Regulation Number
880.6060
Review Panel
HO
Submission Type

Other clearances by Techtrade, LLC

  • K050097 — TECHNO-SCOPE VISUAL STETHOSCOPE (September 30, 2005)

Other clearances for product code KME

  • K944953 — OREX MEDICAL BEDDING (December 2, 1994)
  • K933636 — DISPOSE-A-SHEET (January 26, 1994)
  • K932539 — DOCTOR DOWN --RESCUE WRAP (November 2, 1993)
  • K922143 — AMERICAN BURN SHEET (August 10, 1992)
  • K915303 — FOIL BABY BUNTING (February 20, 1992)
  • K912257 — CHEM-SLEEVE B (December 31, 1991)
  • K911952 — MEDI GUARD UNDERPAD (May 28, 1991)
  • K911953 — MEDI GUARD SHEETS/UNDERLAYS (May 28, 1991)
  • K911948 — MEDI GUARD PILLOWCASE (May 28, 1991)
  • K911950 — MEDI GUARD DRAPES (May 21, 1991)

FDA data resources