510(k) K002105

SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS by Siemens Medical Solutions USA, Inc. — Product Code MLD

K002105 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS". The FDA issued a decision of Substantially Equivalent on December 5, 2000. 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: December 5, 2000
Date Received: July 12, 2000
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 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)
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)

510(k) K002105

Clearance Details

Device Classification

Other clearances by Siemens Medical Solutions USA, Inc.

Other clearances for product code MLD

FDA data resources