FDA 510(k)

AMICI XENON ADMINISTRATION SET

K-Number: K903805 · 1991-01-14

Decision Date1991-01-14

Product CodeIYT

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AMICI XENON ADMINISTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Amici, Inc.. It received FDA 510(k) clearance on 1991-01-14 under 510(k) number K903805. The device is classified under product code IYT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMICI XENON ADMINISTRATION SET?

AMICI XENON ADMINISTRATION SET is a medical device that received FDA 510(k) clearance on 1991-01-14. The listed applicant is Amici, Inc.. The 510(k) number is K903805.

When did AMICI XENON ADMINISTRATION SET receive FDA 510(k) clearance?

AMICI XENON ADMINISTRATION SET received FDA 510(k) clearance on 1991-01-14, under 510(k) number K903805.

Who is the listed applicant for AMICI XENON ADMINISTRATION SET?

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

What is the FDA product code for AMICI XENON ADMINISTRATION SET?

The FDA product code for AMICI XENON ADMINISTRATION SET is IYT.

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Other records listing Amici, Inc. as applicant

K063716AEROSOL SYSTEM K952910THE SWIRLER NEBULIZER K952893THE SWIRLER AEROSOL SYSTEM K904684AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION K903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE K872920AMICI KRYPTON ADMINISTRATION SYSTEM*

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Related Devices (Code: IYT)

K253942Pulmonex II Xenon System (132-503)Mirion Technologies (Capintec), Inc.K200916Patient Administration SetCyclomedica Australia Pty, Ltd.K953513XENON CIRCUITKing Systems Corp.K952223XENON GAS BREATHING CIRCUITIntertech Resources, Inc.K914747XENON CIRCUITGibeck, Inc.K913416TETLEY PATIENT ADMINISTRATION SETTetley Medical , Ltd.

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.