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)

EARCHECK

K-Number: K971859 · 1997-08-18

ApplicantMdi Instruments, Inc.
Decision Date1997-08-18
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EARCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Mdi Instruments, Inc.. It received FDA 510(k) clearance on 1997-08-18 under 510(k) number K971859. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EARCHECK?

EARCHECK is a medical device that received FDA 510(k) clearance on 1997-08-18. The listed applicant is Mdi Instruments, Inc.. The 510(k) number is K971859.

When did EARCHECK receive FDA 510(k) clearance?

EARCHECK received FDA 510(k) clearance on 1997-08-18, under 510(k) number K971859.

Who is the listed applicant for EARCHECK?

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

What is the FDA product code for EARCHECK?

The FDA product code for EARCHECK is ETY.

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 Mdi Instruments, 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.

K970685EARCHECK PRO

Related Devices (Code: ETY)

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.

K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

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.

↑