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FDA 510(k)

SnapShot Freeze 2

K-Number: K183161 · 2019-02-13

Decision Date2019-02-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SnapShot Freeze 2 is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2019-02-13 under approval number K183161. 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 SnapShot Freeze 2?

SnapShot Freeze 2 is a medical device that received FDA 510(k) clearance on 2019-02-13. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K183161.

When was SnapShot Freeze 2 approved by the FDA?

SnapShot Freeze 2 received FDA 510(k) clearance on 2019-02-13, under approval number K183161.

What company makes SnapShot Freeze 2?

SnapShot Freeze 2 is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for SnapShot Freeze 2?

The FDA product code for SnapShot Freeze 2 is JAK.

Other Devices by Ge Medical Systems, LLC

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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.