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)

THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR

K-Number: K850657 · 1985-02-22

ApplicantFlowtronics, Inc.
Decision Date1985-02-22
Product CodeLME
DecisionSubstantially Equivalent

Device Summary

THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Flowtronics, Inc.. It received FDA 510(k) clearance on 1985-02-22 under 510(k) number K850657. The device is classified under product code LME. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR?

THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR is a medical device that received FDA 510(k) clearance on 1985-02-22. The listed applicant is Flowtronics, Inc.. The 510(k) number is K850657.

When did THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR receive FDA 510(k) clearance?

THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR received FDA 510(k) clearance on 1985-02-22, under 510(k) number K850657.

Who is the listed applicant for THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR?

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

What is the FDA product code for THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR?

The FDA product code for THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR is LME.

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

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.

↑