Cardiocap(Tm) Dr-104 Reporter

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K885058 ↗

FDA Product Code

DSF

Device Class

Class I

Regulation

21 CFR Part 870.2810

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Datex AS/3 Patient Monitor

  Class II

  FDA 510(k) K933156 Active Cleared 30 Dec 1994

• Dual Chennel Brain Activity Monitor

  Class II

  FDA 510(k) K843808 Active Cleared 8 Nov 1984

• Pb Graphics Printer and Pb Video Display

  Class II

  FDA 510(k) K863248 Active Cleared 3 Sep 1986

• Capnomac II(Tm) Anesthesia Multigas Monitor

  Class II

  FDA 510(k) K891076 Active Cleared 2 Aug 1989

• Capnomac Ultima Anesthesia Monitor

  Class II

  FDA 510(k) K905754 Active Cleared 17 Jun 1991

• Ngm Gas Module

  Class II

  FDA 510(k) K911647 Active Cleared 19 Sep 1991

See all devices from Datex Division Instrumentarium Corp. →