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FDA 510(k)

MEDIPART XENON BREATHING KIT MP-OIXM-I

K-Number: K850366 · 1985-04-30

ApplicantMedipart Jerry Alexander
Decision Date1985-04-30
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDIPART XENON BREATHING KIT MP-OIXM-I is the device name listed in this FDA 510(k) record. The listed applicant is Medipart Jerry Alexander. It received FDA 510(k) clearance on 1985-04-30 under 510(k) number K850366. 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 MEDIPART XENON BREATHING KIT MP-OIXM-I?

MEDIPART XENON BREATHING KIT MP-OIXM-I is a medical device that received FDA 510(k) clearance on 1985-04-30. The listed applicant is Medipart Jerry Alexander. The 510(k) number is K850366.

When did MEDIPART XENON BREATHING KIT MP-OIXM-I receive FDA 510(k) clearance?

MEDIPART XENON BREATHING KIT MP-OIXM-I received FDA 510(k) clearance on 1985-04-30, under 510(k) number K850366.

Who is the listed applicant for MEDIPART XENON BREATHING KIT MP-OIXM-I?

The FDA 510(k) record lists Medipart Jerry Alexander as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDIPART XENON BREATHING KIT MP-OIXM-I?

The FDA product code for MEDIPART XENON BREATHING KIT MP-OIXM-I is IYT.

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Other records listing Medipart Jerry Alexander 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.

K896885DISPOSABLE RESPIRTORY KIT (MP-200)K896125MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133MK896475DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELDK896124MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133K896476DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELDK894138MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD

View all 49 devices →

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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