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FDA 510(k)

ENTERNAL PUMP & ADMIN. SET 430

K-Number: K831935 · 1983-08-08

ApplicantImed Corp.
Decision Date1983-08-08
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ENTERNAL PUMP & ADMIN. SET 430 is the device name listed in this FDA 510(k) record. The listed applicant is Imed Corp.. It received FDA 510(k) clearance on 1983-08-08 under 510(k) number K831935. 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 ENTERNAL PUMP & ADMIN. SET 430?

ENTERNAL PUMP & ADMIN. SET 430 is a medical device that received FDA 510(k) clearance on 1983-08-08. The listed applicant is Imed Corp.. The 510(k) number is K831935.

When did ENTERNAL PUMP & ADMIN. SET 430 receive FDA 510(k) clearance?

ENTERNAL PUMP & ADMIN. SET 430 received FDA 510(k) clearance on 1983-08-08, under 510(k) number K831935.

Who is the listed applicant for ENTERNAL PUMP & ADMIN. SET 430?

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 ENTERNAL PUMP & ADMIN. SET 430?

The FDA product code for ENTERNAL PUMP & ADMIN. SET 430 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)

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.

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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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