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 SC 8000 BEDSIDE MONITOR

K-Number: K983632 · 1998-11-06

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date1998-11-06
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIEMENS SC 8000 BEDSIDE MONITOR 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 1998-11-06 under 510(k) number K983632. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS SC 8000 BEDSIDE MONITOR?

SIEMENS SC 8000 BEDSIDE MONITOR is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K983632.

When did SIEMENS SC 8000 BEDSIDE MONITOR receive FDA 510(k) clearance?

SIEMENS SC 8000 BEDSIDE MONITOR received FDA 510(k) clearance on 1998-11-06, under 510(k) number K983632.

Who is the listed applicant for SIEMENS SC 8000 BEDSIDE MONITOR?

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 SC 8000 BEDSIDE MONITOR?

The FDA product code for SIEMENS SC 8000 BEDSIDE MONITOR is DSI.

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: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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.

↑