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FDA 510(k)

AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION

K-Number: K904684 · 1991-01-14

ApplicantAmici, Inc.
Decision Date1991-01-14
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION 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 K904684. 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 KRYPTON ADMINISTRATION SYSTEM, MODIFICATION?

AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION 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 K904684.

When did AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION receive FDA 510(k) clearance?

AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION received FDA 510(k) clearance on 1991-01-14, under 510(k) number K904684.

Who is the listed applicant for AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION?

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 KRYPTON ADMINISTRATION SYSTEM, MODIFICATION?

The FDA product code for AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION 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 SYSTEMK903805AMICI XENON ADMINISTRATION SETK903694AMICI TRU-FIT SOFT PLASTIC MOUTHPIECEK872920AMICI KRYPTON ADMINISTRATION SYSTEM*

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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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