FDA 510(k)

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION

K-Number: K063503 · 2007-04-27

ApplicantMallinckrodt Inc., Liebel-Flarsheim Business

Decision Date2007-04-27

Product CodeIZQ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION 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 2007-04-27 under 510(k) number K063503. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION?

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION is a medical device that received FDA 510(k) clearance on 2007-04-27. The listed applicant is Mallinckrodt Inc., Liebel-Flarsheim Business. The 510(k) number is K063503.

When did OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION receive FDA 510(k) clearance?

OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION received FDA 510(k) clearance on 2007-04-27, under 510(k) number K063503.

Who is the listed applicant for OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION?

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 OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION?

The FDA product code for OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION is IZQ.

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Related Devices (Code: IZQ)

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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.