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FDA 510(k)

CT 5300

K-Number: K232491 · 2024-05-03

Decision Date2024-05-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT 5300 is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-05-03 under approval number K232491. 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 CT 5300?

CT 5300 is a medical device that received FDA 510(k) clearance on 2024-05-03. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K232491.

When was CT 5300 approved by the FDA?

CT 5300 received FDA 510(k) clearance on 2024-05-03, under approval number K232491.

What company makes CT 5300?

CT 5300 is manufactured by Philips Healthcare (Suzhou) Co., Ltd..

What is the FDA product code for CT 5300?

The FDA product code for CT 5300 is JAK.

Other Devices by Philips Healthcare (Suzhou) Co., Ltd.

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Related Devices (Code: JAK)

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.