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FDA 510(k)

P105

K-Number: K820827 · 1982-06-25

ApplicantEurotan Intl.
Decision Date1982-06-25
Product Code
DecisionSubstantially Equivalent

Device Summary

P105 is the device name listed in this FDA 510(k) record. The listed applicant is Eurotan Intl.. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K820827. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P105?

P105 is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Eurotan Intl.. The 510(k) number is K820827.

When did P105 receive FDA 510(k) clearance?

P105 received FDA 510(k) clearance on 1982-06-25, under 510(k) number K820827.

Who is the listed applicant for P105?

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

Other records listing Eurotan Intl. 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.

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.

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