FDA 510(k)

CERETOM, MODEL NL3000

K-Number: K051765 · 2005-07-14

Decision Date2005-07-14

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CERETOM, MODEL NL3000 is the device name listed in this FDA 510(k) record. The listed applicant is Neurologica Corporation. It received FDA 510(k) clearance on 2005-07-14 under 510(k) number K051765. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERETOM, MODEL NL3000?

CERETOM, MODEL NL3000 is a medical device that received FDA 510(k) clearance on 2005-07-14. The listed applicant is Neurologica Corporation. The 510(k) number is K051765.

When did CERETOM, MODEL NL3000 receive FDA 510(k) clearance?

CERETOM, MODEL NL3000 received FDA 510(k) clearance on 2005-07-14, under 510(k) number K051765.

Who is the listed applicant for CERETOM, MODEL NL3000?

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

What is the FDA product code for CERETOM, MODEL NL3000?

The FDA product code for CERETOM, MODEL NL3000 is JAK.

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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.