FDA 510(k)

LUNA

K-Number: K982351 · 1998-07-29

Decision Date1998-07-29

Product CodeOLT

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

LUNA is the device name listed in this FDA 510(k) record. The listed applicant is Stellate Systems. It received FDA 510(k) clearance on 1998-07-29 under 510(k) number K982351. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUNA?

LUNA is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Stellate Systems. The 510(k) number is K982351.

When did LUNA receive FDA 510(k) clearance?

LUNA received FDA 510(k) clearance on 1998-07-29, under 510(k) number K982351.

Who is the listed applicant for LUNA?

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

What is the FDA product code for LUNA?

The FDA product code for LUNA is OLT.

Other records listing Stellate Systems 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.