FDA 510(k)

PRECISION THUNIS 800+

K-Number: K061028 · 2006-06-07

Decision Date2006-06-07

Product CodeJAA

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PRECISION THUNIS 800+ is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2006-06-07 under 510(k) number K061028. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRECISION THUNIS 800+?

PRECISION THUNIS 800+ is a medical device that received FDA 510(k) clearance on 2006-06-07. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K061028.

When did PRECISION THUNIS 800+ receive FDA 510(k) clearance?

PRECISION THUNIS 800+ received FDA 510(k) clearance on 2006-06-07, under 510(k) number K061028.

Who is the listed applicant for PRECISION THUNIS 800+?

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

What is the FDA product code for PRECISION THUNIS 800+?

The FDA product code for PRECISION THUNIS 800+ is JAA.

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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.