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510(k) K972121

Device
ACUITY CENTRAL STATION
Applicant
PROTOCOL SYSTEMS, INC.
510(k) number
K972121
Product code
MLD  
Decision
Substantially Equivalent (SESE)
Decision date
1997-11-07
Date received
1997-06-05
Regulation
870.1025
Classification name
Monitor, St Segment With Alarm
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAMES P WELCH
Address
8500 SW Creekside Pl. Beaverton OR US 97008 97008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MLD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K101602VITAL SIGNS MONITORCriticare Systems, Inc.2010-09-01
K080461STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0Philips Medical Systems2008-03-13
K022740DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAREDatex-Ohmeda2002-11-14
K012837MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIESDatex-Ohmeda2001-09-14
K002105SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSISSiemens Medical Solutions USA, Inc.2000-12-05
K992323DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIESDatex-Ohmeda, Inc.1999-11-01
K982104ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500Medical Data Electronics1998-11-25
K974492SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSISSiemens Medical Solutions USA, Inc.1998-02-26
K953175AS/3 ESTPR MODULEDatex Division Instrumentarium Corp.1997-02-06
K960272EAGLE 3000/3100 PATIENT MONITORMarquette Electronics, Inc.1996-10-02
K960934HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24Hewlett-Packard Co.1996-06-14
K935020OMNI-TRAC MODIFICATIONInvivo Research, Inc.1995-04-26
K920429MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEMHewlett-Packard Co.1993-07-20

Legacy Summary#

summary

FDA Review#

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