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FDA 510(k)

XENON XE 127/XE 133 GAS DISPENSER

K-Number: K843640 · 1985-01-14

ApplicantMallinckrodt Critical Care
Decision Date1985-01-14
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XENON XE 127/XE 133 GAS DISPENSER is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1985-01-14 under 510(k) number K843640. 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 XENON XE 127/XE 133 GAS DISPENSER?

XENON XE 127/XE 133 GAS DISPENSER is a medical device that received FDA 510(k) clearance on 1985-01-14. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K843640.

When did XENON XE 127/XE 133 GAS DISPENSER receive FDA 510(k) clearance?

XENON XE 127/XE 133 GAS DISPENSER received FDA 510(k) clearance on 1985-01-14, under 510(k) number K843640.

Who is the listed applicant for XENON XE 127/XE 133 GAS DISPENSER?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XENON XE 127/XE 133 GAS DISPENSER?

The FDA product code for XENON XE 127/XE 133 GAS DISPENSER is IYT.

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Other records listing Mallinckrodt Critical Care as applicant

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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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