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FDA 510(k)

XENON CIRCUIT

K-Number: K914747 · 1992-02-27

ApplicantGibeck, Inc.
Decision Date1992-02-27
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XENON CIRCUIT is the device name listed in this FDA 510(k) record. The listed applicant is Gibeck, Inc.. It received FDA 510(k) clearance on 1992-02-27 under 510(k) number K914747. 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 CIRCUIT?

XENON CIRCUIT is a medical device that received FDA 510(k) clearance on 1992-02-27. The listed applicant is Gibeck, Inc.. The 510(k) number is K914747.

When did XENON CIRCUIT receive FDA 510(k) clearance?

XENON CIRCUIT received FDA 510(k) clearance on 1992-02-27, under 510(k) number K914747.

Who is the listed applicant for XENON CIRCUIT?

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

What is the FDA product code for XENON CIRCUIT?

The FDA product code for XENON CIRCUIT is IYT.

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Other records listing Gibeck, 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.

K965016ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)K964377THERMAL REGULATION SYSTEM BLANKETK964382HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)K960511GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKETK954828ISO-GARD HEPA FILTER-HME, ISO-ARD HEPA FILTER-HME W/PORTK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT

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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.K913416TETLEY PATIENT ADMINISTRATION SETTetley Medical , Ltd.K912626BOLUS XENON CIRCUITVital Signs, Inc.

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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