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FDA 510(k)

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes

K-Number: K193338 · 2020-08-25

Decision Date2020-08-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is a medical device manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-08-25 under approval number K193338. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is a medical device that received FDA 510(k) clearance on 2020-08-25. It is manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K193338.

When was Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes approved by the FDA?

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes received FDA 510(k) clearance on 2020-08-25, under approval number K193338.

What company makes Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is manufactured by Shenzhen Med-Link Electronics Tech Co., Ltd..

What is the FDA product code for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

The FDA product code for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes is FLL.

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Official Source

View on FDA Database →

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