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

FDA 510(k)

MouthLab Vital Signs Monitoring System

K-Number: K201635 · 2021-02-06

ApplicantMultisensor Diagnostics (Dba Aidar Health)
Decision Date2021-02-06
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MouthLab Vital Signs Monitoring System is a medical device manufactured by Multisensor Diagnostics (Dba Aidar Health). It received FDA 510(k) clearance on 2021-02-06 under approval number K201635. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MouthLab Vital Signs Monitoring System?

MouthLab Vital Signs Monitoring System is a medical device that received FDA 510(k) clearance on 2021-02-06. It is manufactured by Multisensor Diagnostics (Dba Aidar Health). The 510(k) number is K201635.

When was MouthLab Vital Signs Monitoring System approved by the FDA?

MouthLab Vital Signs Monitoring System received FDA 510(k) clearance on 2021-02-06, under approval number K201635.

What company makes MouthLab Vital Signs Monitoring System?

MouthLab Vital Signs Monitoring System is manufactured by Multisensor Diagnostics (Dba Aidar Health).

What is the FDA product code for MouthLab Vital Signs Monitoring System?

The FDA product code for MouthLab Vital Signs Monitoring System is MWI.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT06561828 Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026)

Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

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.

↑