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FDA 510(k)

truFreeze System

K-Number: K163244 · 2017-05-24

ApplicantCSA Medical, Inc.
Decision Date2017-05-24
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

truFreeze System is the device name listed in this FDA 510(k) record. The listed applicant is CSA Medical, Inc.. It received FDA 510(k) clearance on 2017-05-24 under 510(k) number K163244. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the truFreeze System?

truFreeze System is a medical device that received FDA 510(k) clearance on 2017-05-24. The listed applicant is CSA Medical, Inc.. The 510(k) number is K163244.

When did truFreeze System receive FDA 510(k) clearance?

truFreeze System received FDA 510(k) clearance on 2017-05-24, under 510(k) number K163244.

Who is the listed applicant for truFreeze System?

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

What is the FDA product code for truFreeze System?

The FDA product code for truFreeze System is GEH.

Other records listing CSA Medical, Inc. as applicant

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Related Devices (Code: GEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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