FDA 510(k)

INFINIA LIGHTSPEED

K-Number: K043381 · 2004-12-23

Decision Date2004-12-23

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

INFINIA LIGHTSPEED is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems F.I. Haifa. It received FDA 510(k) clearance on 2004-12-23 under 510(k) number K043381. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINIA LIGHTSPEED?

INFINIA LIGHTSPEED is a medical device that received FDA 510(k) clearance on 2004-12-23. The listed applicant is Ge Medical Systems F.I. Haifa. The 510(k) number is K043381.

When did INFINIA LIGHTSPEED receive FDA 510(k) clearance?

INFINIA LIGHTSPEED received FDA 510(k) clearance on 2004-12-23, under 510(k) number K043381.

Who is the listed applicant for INFINIA LIGHTSPEED?

The FDA 510(k) record lists Ge Medical Systems F.I. Haifa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINIA LIGHTSPEED?

The FDA product code for INFINIA LIGHTSPEED is KPS.

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Other records listing Ge Medical Systems F.I. Haifa as applicant

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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.