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FDA 510(k)

XENON DELIVERY SYSTEM

K-Number: K820143 · 1982-03-02

ApplicantVital Signs, Inc.
Decision Date1982-03-02
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XENON DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vital Signs, Inc.. It received FDA 510(k) clearance on 1982-03-02 under 510(k) number K820143. 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 DELIVERY SYSTEM?

XENON DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is Vital Signs, Inc.. The 510(k) number is K820143.

When did XENON DELIVERY SYSTEM receive FDA 510(k) clearance?

XENON DELIVERY SYSTEM received FDA 510(k) clearance on 1982-03-02, under 510(k) number K820143.

Who is the listed applicant for XENON DELIVERY SYSTEM?

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

What is the FDA product code for XENON DELIVERY SYSTEM?

The FDA product code for XENON DELIVERY SYSTEM is IYT.

Related Clinical Trials

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Other records listing Vital Signs, 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.

K112902ENFLOW IV FLUID WARMERK041309IMASK TMK030985BREAS PV 10I CPAP SYSTEM, MODEL PV 10IK022402DISPOSABLE PRESSURE MANOMETERK021315SURE-LOKK002454BREAS HA50 HUMIDIFIER, MODEL HA50

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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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