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FDA 510(k)

ACCUSET (R) CASSETTE

K-Number: K820726 · 1982-04-14

ApplicantImed Ireland, Ltd.
Decision Date1982-04-14
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ACCUSET (R) CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Imed Ireland, Ltd.. It received FDA 510(k) clearance on 1982-04-14 under 510(k) number K820726. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUSET (R) CASSETTE?

ACCUSET (R) CASSETTE is a medical device that received FDA 510(k) clearance on 1982-04-14. The listed applicant is Imed Ireland, Ltd.. The 510(k) number is K820726.

When did ACCUSET (R) CASSETTE receive FDA 510(k) clearance?

ACCUSET (R) CASSETTE received FDA 510(k) clearance on 1982-04-14, under 510(k) number K820726.

Who is the listed applicant for ACCUSET (R) CASSETTE?

The FDA 510(k) record lists Imed Ireland, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCUSET (R) CASSETTE?

The FDA product code for ACCUSET (R) CASSETTE is FRN.

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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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