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FDA 510(k)

SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5

K-Number: K020929 · 2002-04-03

ApplicantGE Medical Systems
Decision Date2002-04-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2002-04-03 under 510(k) number K020929. 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 SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5?

SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is GE Medical Systems. The 510(k) number is K020929.

When did SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 receive FDA 510(k) clearance?

SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 received FDA 510(k) clearance on 2002-04-03, under 510(k) number K020929.

Who is the listed applicant for SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5?

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

What is the FDA product code for SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5?

The FDA product code for SMARTSCORE 3.5; SMARTSCORE 4.0; SMARTSCORE 4.5 is JAK.

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Related Devices (Code: 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.

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