FDA 510(k)

OPTISTAR MR INJECTOR SYSTEM

K-Number: K984088 · 1999-12-06

ApplicantMallinckrodt Inc., Liebel-Flarsheim Business

Decision Date1999-12-06

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPTISTAR MR INJECTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Inc., Liebel-Flarsheim Business. It received FDA 510(k) clearance on 1999-12-06 under 510(k) number K984088. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTISTAR MR INJECTOR SYSTEM?

OPTISTAR MR INJECTOR SYSTEM is a medical device that received FDA 510(k) clearance on 1999-12-06. The listed applicant is Mallinckrodt Inc., Liebel-Flarsheim Business. The 510(k) number is K984088.

When did OPTISTAR MR INJECTOR SYSTEM receive FDA 510(k) clearance?

OPTISTAR MR INJECTOR SYSTEM received FDA 510(k) clearance on 1999-12-06, under 510(k) number K984088.

Who is the listed applicant for OPTISTAR MR INJECTOR SYSTEM?

The FDA 510(k) record lists Mallinckrodt Inc., Liebel-Flarsheim Business as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTISTAR MR INJECTOR SYSTEM?

The FDA product code for OPTISTAR MR INJECTOR SYSTEM is DXT.

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Other records listing Mallinckrodt Inc., Liebel-Flarsheim Business as applicant

K082212SYRINGE WITH HANDI-FIL K073592OPTISTAR ELITE INJECTION SYSTEM K063503OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION K042744OPTIV ANTAGE DH POWER INJECTION SYSTEM K031339OPTIBOLUS K022116ELPH INJECTION SYSTEM

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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.