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510(k) K080461

STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 by Philips Medical Systems — Product Code MLD

K080461 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0". The FDA issued a decision of Substantially Equivalent on March 13, 2008. The device falls under product code MLD (Monitor, St Segment With Alarm), a Class II device regulated under 21 CFR 870.1025. Philips Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2008
Date Received
February 20, 2008
Clearance Type
Special
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 Philips Medical Systems

  • K253670 — SmartCT (R3.0 (L10)) (July 10, 2026)
  • K254186 — Azurion R3.1 (January 16, 2026)
  • K251827 — Azurion R3.1 (October 24, 2025)
  • K212704 — Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasoun (September 24, 2021)
  • K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound (September 8, 2021)
  • K210560 — Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Car (June 30, 2021)
  • K191738 — PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardio (September 29, 2020)
  • K192875 — Philips Biosensor BX100 (April 16, 2020)
  • K183387 — M3290B Patient Information Center iX (August 6, 2019)
  • K180017 — MX40 Release C.01 (July 24, 2018)

Other clearances for product code MLD

  • K101602 — VITAL SIGNS MONITOR (September 1, 2010)
  • 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)
  • K992323 — DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES (November 1, 1999)
  • 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