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FDA 510(k)

MODEL XE-103 XENON/MASTER II

K-Number: K863996 · 1986-11-04

ApplicantMedi Nuclear Corp., Inc.
Decision Date1986-11-04
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL XE-103 XENON/MASTER II 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 1986-11-04 under 510(k) number K863996. 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 MODEL XE-103 XENON/MASTER II?

MODEL XE-103 XENON/MASTER II is a medical device that received FDA 510(k) clearance on 1986-11-04. The listed applicant is Medi Nuclear Corp., Inc.. The 510(k) number is K863996.

When did MODEL XE-103 XENON/MASTER II receive FDA 510(k) clearance?

MODEL XE-103 XENON/MASTER II received FDA 510(k) clearance on 1986-11-04, under 510(k) number K863996.

Who is the listed applicant for MODEL XE-103 XENON/MASTER II?

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 MODEL XE-103 XENON/MASTER II?

The FDA product code for MODEL XE-103 XENON/MASTER II 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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