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FDA 510(k)

AMICI XENON REBREATHING SYSTEM*

K-Number: K865084 · 1987-03-03

ApplicantAmici, Inc.
Decision Date1987-03-03
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMICI XENON REBREATHING SYSTEM* is the device name listed in this FDA 510(k) record. The listed applicant is Amici, Inc.. It received FDA 510(k) clearance on 1987-03-03 under 510(k) number K865084. 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 REBREATHING SYSTEM*?

AMICI XENON REBREATHING SYSTEM* is a medical device that received FDA 510(k) clearance on 1987-03-03. The listed applicant is Amici, Inc.. The 510(k) number is K865084.

When did AMICI XENON REBREATHING SYSTEM* receive FDA 510(k) clearance?

AMICI XENON REBREATHING SYSTEM* received FDA 510(k) clearance on 1987-03-03, under 510(k) number K865084.

Who is the listed applicant for AMICI XENON REBREATHING SYSTEM*?

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 REBREATHING SYSTEM*?

The FDA product code for AMICI XENON REBREATHING SYSTEM* is IYT.

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Other records listing Amici, Inc. 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.

K063716AEROSOL SYSTEMK952910THE SWIRLER NEBULIZERK952893THE SWIRLER AEROSOL SYSTEMK904684AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATIONK903805AMICI XENON ADMINISTRATION SETK903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE

View all 8 devices →

Related Devices (Code: IYT)

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.

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.

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