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FDA 510(k)

XENAMATIC SERIES OF XENON REBREATH DEV

K-Number: K820571 · 1982-03-31

ApplicantDiversified P.A.
Decision Date1982-03-31
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XENAMATIC SERIES OF XENON REBREATH DEV is the device name listed in this FDA 510(k) record. The listed applicant is Diversified P.A.. It received FDA 510(k) clearance on 1982-03-31 under 510(k) number K820571. 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 XENAMATIC SERIES OF XENON REBREATH DEV?

XENAMATIC SERIES OF XENON REBREATH DEV is a medical device that received FDA 510(k) clearance on 1982-03-31. The listed applicant is Diversified P.A.. The 510(k) number is K820571.

When did XENAMATIC SERIES OF XENON REBREATH DEV receive FDA 510(k) clearance?

XENAMATIC SERIES OF XENON REBREATH DEV received FDA 510(k) clearance on 1982-03-31, under 510(k) number K820571.

Who is the listed applicant for XENAMATIC SERIES OF XENON REBREATH DEV?

The FDA 510(k) record lists Diversified P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XENAMATIC SERIES OF XENON REBREATH DEV?

The FDA product code for XENAMATIC SERIES OF XENON REBREATH DEV is IYT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Diversified P.A. 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.

K812613VIDICAM 200

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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