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)

MODEL MI 44 TYMPANOMETER

K-Number: K060885 · 2006-06-05

ApplicantMaico-Diagnostics
Decision Date2006-06-05
Product CodeEWO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL MI 44 TYMPANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Maico-Diagnostics. It received FDA 510(k) clearance on 2006-06-05 under 510(k) number K060885. The device is classified under product code EWO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL MI 44 TYMPANOMETER?

MODEL MI 44 TYMPANOMETER is a medical device that received FDA 510(k) clearance on 2006-06-05. The listed applicant is Maico-Diagnostics. The 510(k) number is K060885.

When did MODEL MI 44 TYMPANOMETER receive FDA 510(k) clearance?

MODEL MI 44 TYMPANOMETER received FDA 510(k) clearance on 2006-06-05, under 510(k) number K060885.

Who is the listed applicant for MODEL MI 44 TYMPANOMETER?

The FDA 510(k) record lists Maico-Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL MI 44 TYMPANOMETER?

The FDA product code for MODEL MI 44 TYMPANOMETER is EWO.

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 Maico-Diagnostics 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.

K082035MAICO MB 11 WITH BERAPHONE PROBEK003913HINT AUDIOMETER, OR HINT

Related Devices (Code: EWO)

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.

K234095OtoNova/OtoNova ProOtodynamicsK240430Otoport ProOtodynamics, Ltd.K231545hearOAEHearx SA (Pty) , Ltd.K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbHK191372LyraInteracoustics A/SK180287GSI CortiGrason-Stadler, Inc.

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.

↑