Respitrace Plus

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K894973 ↗

FDA Product Code

FLS

Device Class

Class II

Regulation

21 CFR Part 868.2377

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Intergrated Monitoring Archiving and Communications Systems (Imacs)

  Class II

  FDA 510(k) K941762 Active Cleared 22 Feb 1995

• I.m Probes

  Class I

  FDA 510(k) K802951 Active Cleared 17 Dec 1980

• Cardiolipin G EIA Test System

  Class II

  FDA 510(k) K946215 Active Cleared 24 Jan 1996

• Cardiolipin a Eia Test System

  Class II

  FDA 510(k) K946216 Active Cleared 24 Jan 1996

• Redfield Infrared Coagulator

  Class II

  FDA 510(k) K950836 Active Cleared 24 Mar 1995

• Coopersurgical Infrared Coagulator

  Class II

  FDA 510(k) K974168 Active Cleared 23 Jan 1998

See all devices from Hogan & Hartson →