Asc-950 ECG Amplifier

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K894161 ↗

FDA Product Code

DRR

Device Class

Class II

Regulation

21 CFR Part 870.2050

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Dash IV

  Class I

  FDA 510(k) K912929 Active Cleared 13 Aug 1991

• Astro-Med Asc-951 Pressure Processor

  Class II

  FDA 510(k) K894295 Active Cleared 18 Jan 1990

• K3 System

  Class II

  FDA 510(k) K934644 Active Cleared 1 Nov 1994

• MT9000 Chart Recorder

  Class II

  FDA 510(k) K892067 Active Cleared 5 Jun 1989

• Asc-952 Physiological Amplifier

  Class II

  FDA 510(k) K894735 Active Cleared 18 Sep 1989

• Aura-Psg

  Class II

  FDA 510(k) K050425 Active Cleared 20 Oct 2005

See all devices from Astro-Med, Inc. →