Atlas FDA

EAGLE 3000/3100 PATIENT MONITOR

FDA 510(k) clearance K960272 · decided 1996-10-02

Clearance details

K-number
K960272
Device name
EAGLE 3000/3100 PATIENT MONITOR
Applicant
Marquette Electronics, Inc.
Decision
Substantially Equivalent
Date received
1996-01-18
Decision date
1996-10-02
Days to decision
258 days
Clearance type
Traditional
Product code
MLD
Device class
2
Regulation number
870.1025
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Milwaukee, WI, US
Third-party review
No
Expedited review
No

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RecordFirmDate
VITAL SIGNS MONITOR (K101602)Criticare Systems, Inc.2010-09-01
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DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE (K022740)Datex-Ohmeda2002-11-14
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES (K012837)Datex-Ohmeda2001-09-14
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
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

No recalls on record reference this clearance.