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)

506 NON-INVASIVE VITAL SIGNS MONITOR

K-Number: K884216 · 1989-03-16

ApplicantCriticare Systems, Inc.
Decision Date1989-03-16
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

506 NON-INVASIVE VITAL SIGNS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Criticare Systems, Inc.. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K884216. 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 506 NON-INVASIVE VITAL SIGNS MONITOR?

506 NON-INVASIVE VITAL SIGNS MONITOR is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Criticare Systems, Inc.. The 510(k) number is K884216.

When did 506 NON-INVASIVE VITAL SIGNS MONITOR receive FDA 510(k) clearance?

506 NON-INVASIVE VITAL SIGNS MONITOR received FDA 510(k) clearance on 1989-03-16, under 510(k) number K884216.

Who is the listed applicant for 506 NON-INVASIVE VITAL SIGNS MONITOR?

The FDA 510(k) record lists Criticare Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 506 NON-INVASIVE VITAL SIGNS MONITOR?

The FDA product code for 506 NON-INVASIVE VITAL SIGNS 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 Criticare Systems, 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.

K101602VITAL SIGNS MONITORK091050506CN PATIENT MONITORK0425698600 VITAL SIGNS MONITORK030613VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100K022435507EL VITAL SIGNS MONITORK0120598100/8500 VITAL SIGNS MONITOR

View all 22 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.

↑