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FDA 510(k)

DISPENSER, GAS XENON

K-Number: K781107 · 1978-07-17

ApplicantMallinckrodt Critical Care
Decision Date1978-07-17
Product CodeIYT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DISPENSER, GAS XENON is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1978-07-17 under 510(k) number K781107. 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 DISPENSER, GAS XENON?

DISPENSER, GAS XENON is a medical device that received FDA 510(k) clearance on 1978-07-17. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K781107.

When did DISPENSER, GAS XENON receive FDA 510(k) clearance?

DISPENSER, GAS XENON received FDA 510(k) clearance on 1978-07-17, under 510(k) number K781107.

Who is the listed applicant for DISPENSER, GAS XENON?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPENSER, GAS XENON?

The FDA product code for DISPENSER, GAS XENON is IYT.

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Related Devices (Code: IYT)

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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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