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)

Visby Medical Respiratory Health Test

K-Number: K242526 · 2025-02-19

ApplicantVisby Medical, Inc.
Decision Date2025-02-19
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Visby Medical Respiratory Health Test is a medical device manufactured by Visby Medical, Inc.. It received FDA 510(k) clearance on 2025-02-19 under approval number K242526. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Visby Medical Respiratory Health Test?

Visby Medical Respiratory Health Test is a medical device that received FDA 510(k) clearance on 2025-02-19. It is manufactured by Visby Medical, Inc.. The 510(k) number is K242526.

When was Visby Medical Respiratory Health Test approved by the FDA?

Visby Medical Respiratory Health Test received FDA 510(k) clearance on 2025-02-19, under approval number K242526.

What company makes Visby Medical Respiratory Health Test?

Visby Medical Respiratory Health Test is manufactured by Visby Medical, Inc..

What is the FDA product code for Visby Medical Respiratory Health Test?

The FDA product code for Visby Medical Respiratory Health Test is QOF.

Related Clinical Trials

NCT04456569 Geniculate Artery Embolization for Osteoarthritis ACTIVE_NOT_RECRUITING NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT03258580 Sociocultural & Biobehavioral Influences on Pain Expression and Assessment RECRUITING NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42067025 Regulating cybersecurity in digital health: A comparative policy analysis of the USA, EU, and India. Annales pharmaceutiques francaises (2026) PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026)

Other Devices by Visby Medical, Inc.

K251501Visby Medical Men's Sexual Health Test DEN240020Visby Medical Women's Sexual Health Test

Related Devices (Code: QOF)

DEN200031BioFire Respiratory Panel 2.1 (RP2.1)Biofire Diagnostics, LLC K231481Xpert Xpress CoV-2/Flu/RSV plusCepheid® K230956BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ SystemBd Integrated Diagnostic Solutions / K223591cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemRoche Molecular Systems, Inc. K222736Panther Fusion SARS-CoV-2/Flu A/B/RSV AssayHologic, Inc. K230719BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniBiofire Diagnostics, LLC

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.

↑