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FDA 510(k)

AMENDMENTS TO MULTIFOCUS

K-Number: K951002 · 1995-09-18

ApplicantOticon A/S
Decision Date1995-09-18
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AMENDMENTS TO MULTIFOCUS is the device name listed in this FDA 510(k) record. The listed applicant is Oticon A/S. It received FDA 510(k) clearance on 1995-09-18 under 510(k) number K951002. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMENDMENTS TO MULTIFOCUS?

AMENDMENTS TO MULTIFOCUS is a medical device that received FDA 510(k) clearance on 1995-09-18. The listed applicant is Oticon A/S. The 510(k) number is K951002.

When did AMENDMENTS TO MULTIFOCUS receive FDA 510(k) clearance?

AMENDMENTS TO MULTIFOCUS received FDA 510(k) clearance on 1995-09-18, under 510(k) number K951002.

Who is the listed applicant for AMENDMENTS TO MULTIFOCUS?

The FDA 510(k) record lists Oticon A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMENDMENTS TO MULTIFOCUS?

The FDA product code for AMENDMENTS TO MULTIFOCUS is ESD.

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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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