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FDA 510(k)

BOLUS XENON CIRCUIT

K-Number: K912626 · 1991-08-02

ApplicantVital Signs, Inc.
Decision Date1991-08-02
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BOLUS XENON CIRCUIT 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 1991-08-02 under 510(k) number K912626. 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 BOLUS XENON CIRCUIT?

BOLUS XENON CIRCUIT is a medical device that received FDA 510(k) clearance on 1991-08-02. The listed applicant is Vital Signs, Inc.. The 510(k) number is K912626.

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

BOLUS XENON CIRCUIT received FDA 510(k) clearance on 1991-08-02, under 510(k) number K912626.

Who is the listed applicant for BOLUS XENON CIRCUIT?

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 BOLUS XENON CIRCUIT?

The FDA product code for BOLUS XENON CIRCUIT is IYT.

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Other records listing Vital Signs, Inc. 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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