FDA 510(k)

INTEGRATED REGISTRATION

K-Number: K093234 · 2009-10-30

Decision Date2009-10-30

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

INTEGRATED REGISTRATION is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2009-10-30 under 510(k) number K093234. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRATED REGISTRATION?

INTEGRATED REGISTRATION is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is GE Medical Systems SCS. The 510(k) number is K093234.

When did INTEGRATED REGISTRATION receive FDA 510(k) clearance?

INTEGRATED REGISTRATION received FDA 510(k) clearance on 2009-10-30, under 510(k) number K093234.

Who is the listed applicant for INTEGRATED REGISTRATION?

The FDA 510(k) record lists GE Medical Systems SCS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGRATED REGISTRATION?

The FDA product code for INTEGRATED REGISTRATION is LLZ.

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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.