FDA 510(k)

SAM Model 9-10000

K-Number: K240100 · 2024-06-04

Decision Date2024-06-04

Product CodeMNR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SAM Model 9-10000 is a medical device manufactured by Snap Diagnostics, LLC. It received FDA 510(k) clearance on 2024-06-04 under approval number K240100. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAM Model 9-10000?

SAM Model 9-10000 is a medical device that received FDA 510(k) clearance on 2024-06-04. It is manufactured by Snap Diagnostics, LLC. The 510(k) number is K240100.

When was SAM Model 9-10000 approved by the FDA?

SAM Model 9-10000 received FDA 510(k) clearance on 2024-06-04, under approval number K240100.

What company makes SAM Model 9-10000?

SAM Model 9-10000 is manufactured by Snap Diagnostics, LLC.

What is the FDA product code for SAM Model 9-10000?

The FDA product code for SAM Model 9-10000 is MNR.

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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.