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FDA 510(k)

SnapShot Freeze 2

K-Number: K183161 · 2019-02-13

ApplicantGe Medical Systems, LLC
Decision Date2019-02-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SnapShot Freeze 2 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 2019-02-13 under 510(k) 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. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K183161.

When did SnapShot Freeze 2 receive FDA 510(k) clearance?

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

Who is the listed applicant for SnapShot Freeze 2?

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 SnapShot Freeze 2?

The FDA product code for SnapShot Freeze 2 is 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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