Engstrom Hmef 1000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K964204 ↗

FDA Product Code

CAH

Device Class

Class II

Regulation

21 CFR Part 868.5260

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Cs/3(Tm) Monitors*

  Class II

  FDA 510(k) K974792 Active Cleared 2 Jun 1998

• Trip Tonometry Catheter, 18F

  Class II

  FDA 510(k) K980384 Active Cleared 1 May 1998

• Cs/3 Arrhythmia Workstation

  Class II

  FDA 510(k) K974747 Active Cleared 23 Apr 1998

• Datex-Engstrom Light Monitor Models F-LM1, F-LMP1

  Class II

  FDA 510(k) K981378 Active Cleared 3 Nov 1998

• Datex-Engstrom Network

  Class II

  FDA 510(k) K974101 Active Cleared 6 Feb 1998

• Trip Tonometry Catheter, 16F

  Class II

  FDA 510(k) K983366 Active Cleared 23 Dec 1998

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