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FDA 510(k)

StoneChecker

K-Number: K191530 · 2019-09-26

ApplicantImaging Biometrics, LLC
Decision Date2019-09-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

StoneChecker is a medical device manufactured by Imaging Biometrics, LLC. It received FDA 510(k) clearance on 2019-09-26 under approval number K191530. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StoneChecker?

StoneChecker is a medical device that received FDA 510(k) clearance on 2019-09-26. It is manufactured by Imaging Biometrics, LLC. The 510(k) number is K191530.

When was StoneChecker approved by the FDA?

StoneChecker received FDA 510(k) clearance on 2019-09-26, under approval number K191530.

What company makes StoneChecker?

StoneChecker is manufactured by Imaging Biometrics, LLC.

What is the FDA product code for StoneChecker?

The FDA product code for StoneChecker is LLZ.

Other Devices by Imaging Biometrics, LLC

K201092LSN

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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