Biologic-Dt Machine, Model Dt-1000 and Biologic-Dt Treatment Kit, Model Dt-1000-Tk

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K984546 ↗

FDA Product Code

FLD

Models / Variants

Dt-1000

Biologic-Dt Treatment Kit

Model Dt-1000-Tk

Device Class

Class II

Regulation

21 CFR Part 876.5870

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Biologic Dt-1000 Machine

  Class II

  FDA 510(k) K923046 Active Cleared 30 Sep 1994

• Thermochem-Ht System

  Class II

  FDA 510(k) K993330 Active Cleared 30 Dec 1999

• Biologic-Dt System

  Class II

  FDA 510(k) K953751 Active Cleared 15 Feb 1996

• Biologic-Dt System (Biologic-Dt-1000 with Dt-1000-Tk)

  Class II

  FDA 510(k) K992196 Active Cleared 10 Sep 1999