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510(k) K992323

DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES by Datex-Ohmeda, Inc. — Product Code MLD

K992323 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda, Inc. for the device "DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on November 1, 1999. The device falls under product code MLD (Monitor, St Segment With Alarm), a Class II device regulated under 21 CFR 870.1025. Datex-Ohmeda, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1999
Date Received
July 12, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, St Segment With Alarm
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Datex-Ohmeda, Inc.

  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K210384 — CARESCAPE R860 (November 4, 2021)
  • K172702 — Tec 820, Tec 850 (January 4, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K151570 — Carestation 620/650/650C (January 21, 2016)
  • K142679 — CARESCAPE R860 (June 12, 2015)
  • K143530 — Aespire View (April 24, 2015)
  • K140575 — ENGSTROM CARESTATION, ENGSTROM PRO (February 3, 2015)

Other clearances for product code MLD

  • K101602 — VITAL SIGNS MONITOR (September 1, 2010)
  • K080461 — STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 (March 13, 2008)
  • K022740 — DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAR (November 14, 2002)
  • K012837 — MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES (September 14, 2001)
  • K002105 — SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS (December 5, 2000)
  • K982104 — ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (November 25, 1998)
  • K974492 — SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYS (February 26, 1998)
  • K972121 — ACUITY CENTRAL STATION (November 7, 1997)
  • K953175 — AS/3 ESTPR MODULE (February 6, 1997)
  • K960272 — EAGLE 3000/3100 PATIENT MONITOR (October 2, 1996)

FDA data resources