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FDA 510(k)

IMED ACCUSET CASSETTE

K-Number: K812035 · 1981-07-28

ApplicantImed Corp.
Decision Date1981-07-28
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

IMED ACCUSET CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Imed Corp.. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K812035. 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 IMED ACCUSET CASSETTE?

IMED ACCUSET CASSETTE is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is Imed Corp.. The 510(k) number is K812035.

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

IMED ACCUSET CASSETTE received FDA 510(k) clearance on 1981-07-28, under 510(k) number K812035.

Who is the listed applicant for IMED ACCUSET CASSETTE?

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

What is the FDA product code for IMED ACCUSET CASSETTE?

The FDA product code for IMED ACCUSET CASSETTE is FRN.

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Other records listing Imed Corp. 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.

K960512GEMINI PC-ITXK953896THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETSK950153VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVESK951922ADMINISTRATION SETS WITH BALL FLOATK950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETSK944320VENTED/NON-VENTED GEMINI ADMINISTRATION SET

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Related Devices (Code: FRN)

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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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