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510(k) K974492

SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS by Siemens Medical Solutions USA, Inc. — Product Code MLD

K974492 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS". The FDA issued a decision of Substantially Equivalent on February 26, 1998. The device falls under product code MLD (Monitor, St Segment With Alarm), a Class II device regulated under 21 CFR 870.1025. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1998
Date Received
November 28, 1997
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 Siemens Medical Solutions USA, Inc.

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  • K260844 — ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ult (June 16, 2026)
  • K261315 — Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.spect (May 21, 2026)
  • K254184 — syngo Application Software (April 29, 2026)
  • K254173 — ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (April 24, 2026)
  • K253752 — ARTIS genio floor; ARTIS icono.explore floor (April 23, 2026)
  • K253574 — SOMATOM X.cite; SOMATOM X.ceed (March 20, 2026)
  • K254016 — MI View&GO (February 10, 2026)
  • K253487 — ACUSON Maple Diagnostic Ultrasound System; ACUSON Maple Select Diagnostic Ultras (November 17, 2025)

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)
  • 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)
  • 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