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FDA 510(k)

GEMINI PC-ITX

K-Number: K960512 · 1996-11-21

ApplicantImed Corp.
Decision Date1996-11-21
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GEMINI PC-ITX is the device name listed in this FDA 510(k) record. The listed applicant is Imed Corp.. It received FDA 510(k) clearance on 1996-11-21 under 510(k) number K960512. 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 GEMINI PC-ITX?

GEMINI PC-ITX is a medical device that received FDA 510(k) clearance on 1996-11-21. The listed applicant is Imed Corp.. The 510(k) number is K960512.

When did GEMINI PC-ITX receive FDA 510(k) clearance?

GEMINI PC-ITX received FDA 510(k) clearance on 1996-11-21, under 510(k) number K960512.

Who is the listed applicant for GEMINI PC-ITX?

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 GEMINI PC-ITX?

The FDA product code for GEMINI PC-ITX 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.

K953896THE 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 SETK945070VERSASAE PLASTIC CANNULA- 11 GAUGE

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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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