Atlas FDA

MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES

FDA 510(k) clearance K012837 · decided 2001-09-14

Clearance details

K-number
K012837
Device name
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
Applicant
Datex-Ohmeda
Decision
Substantially Equivalent
Date received
2001-08-23
Decision date
2001-09-14
Days to decision
22 days
Clearance type
Special
Product code
MLD
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Needham, MA, US
Third-party review
No
Expedited review
No

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SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS (K002105)Siemens Medical Solutions USA, Inc.2000-12-05
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (K992323)Datex-Ohmeda, Inc.1999-11-01
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500 (K982104)Medical Data Electronics1998-11-25
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS (K974492)Siemens Medical Solutions USA, Inc.1998-02-26
ACUITY CENTRAL STATION (K972121)Protocol Systems, Inc.1997-11-07
AS/3 ESTPR MODULE (K953175)Datex Division Instrumentarium Corp.1997-02-06
EAGLE 3000/3100 PATIENT MONITOR (K960272)Marquette Electronics, Inc.1996-10-02
HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 (K960934)Hewlett-Packard Co.1996-06-14
OMNI-TRAC MODIFICATION (K935020)Invivo Research, Inc.1995-04-26

Recalls involving this device

RecordFirmDate
Datex-Ohmeda Cardiocap/5 Patient Monitors recall (Z-0143-04)Datex-Ohmeda Inc2004-07-20
Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option recall (Z-0611-03)Datex-Ohmeda2003-03-05