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FDA 510(k)

MEDI/NUCLEAR #XE-102 XENON/MASTER

K-Number: K810819 · 1981-04-14

ApplicantMedi Nuclear Corp., Inc.
Decision Date1981-04-14
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDI/NUCLEAR #XE-102 XENON/MASTER is the device name listed in this FDA 510(k) record. The listed applicant is Medi Nuclear Corp., Inc.. It received FDA 510(k) clearance on 1981-04-14 under 510(k) number K810819. 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 MEDI/NUCLEAR #XE-102 XENON/MASTER?

MEDI/NUCLEAR #XE-102 XENON/MASTER is a medical device that received FDA 510(k) clearance on 1981-04-14. The listed applicant is Medi Nuclear Corp., Inc.. The 510(k) number is K810819.

When did MEDI/NUCLEAR #XE-102 XENON/MASTER receive FDA 510(k) clearance?

MEDI/NUCLEAR #XE-102 XENON/MASTER received FDA 510(k) clearance on 1981-04-14, under 510(k) number K810819.

Who is the listed applicant for MEDI/NUCLEAR #XE-102 XENON/MASTER?

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

What is the FDA product code for MEDI/NUCLEAR #XE-102 XENON/MASTER?

The FDA product code for MEDI/NUCLEAR #XE-102 XENON/MASTER is IYT.

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Other records listing Medi Nuclear Corp., 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.

K082541HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEMK080969HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510K080657NEB-90 LARGE VOLUME MEDICATION NEBULIZERK915075NEBULIZER (DIRECT PATIENT INTERFACE)K865107AERO-VENT AEROSOL UNITK865093SAFE-T-SHIELD MOUTHPIECE

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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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