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FDA 510(k)

HEARING AIDS MODELS IMS, ISD, ICL & IHX

K-Number: K844478 · 1985-02-28

ApplicantThe Ite Co.
Decision Date1985-02-28
Product Code
DecisionSubstantially Equivalent

Device Summary

HEARING AIDS MODELS IMS, ISD, ICL & IHX is the device name listed in this FDA 510(k) record. The listed applicant is The Ite Co.. It received FDA 510(k) clearance on 1985-02-28 under 510(k) number K844478. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEARING AIDS MODELS IMS, ISD, ICL & IHX?

HEARING AIDS MODELS IMS, ISD, ICL & IHX is a medical device that received FDA 510(k) clearance on 1985-02-28. The listed applicant is The Ite Co.. The 510(k) number is K844478.

When did HEARING AIDS MODELS IMS, ISD, ICL & IHX receive FDA 510(k) clearance?

HEARING AIDS MODELS IMS, ISD, ICL & IHX received FDA 510(k) clearance on 1985-02-28, under 510(k) number K844478.

Who is the listed applicant for HEARING AIDS MODELS IMS, ISD, ICL & IHX?

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

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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