Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS

K-Number: K002105 · 2000-12-05

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2000-12-05
Product CodeMLD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2000-12-05 under 510(k) number K002105. The device is classified under product code MLD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS?

SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS is a medical device that received FDA 510(k) clearance on 2000-12-05. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K002105.

When did SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS receive FDA 510(k) clearance?

SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS received FDA 510(k) clearance on 2000-12-05, under 510(k) number K002105.

Who is the listed applicant for SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS?

The FDA product code for SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS is MLD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Siemens Medical Solutions USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260055syngo.CT Brain QuantificationK261696ACUNAV Luxera 4D ICE CatheterK260488MULTIX Impact; MULTIX Impact CK253786syngo.CT Coronary CockpitK253678MAMMOMAT B.brilliant (11372950)K260844ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System

View all 732 devices →

Related Devices (Code: MLD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101602VITAL SIGNS MONITORCriticare Systems, Inc.K080461STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0Philips Medical SystemsK022740DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWAREDatex-OhmedaK012837MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIESDatex-OhmedaK992323DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIESDatex-Ohmeda, Inc.K982104ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500Medical Data Electronics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑