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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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2020-08-25 under 510(k) 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. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K193338.

When did Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes receive FDA 510(k) clearance?

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

Who is the listed applicant for Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes?

The FDA 510(k) record lists Shenzhen Med-Link Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Shenzhen Med-Link Electronics Tech Co., Ltd. as applicant

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.

View all 11 devices →

Related Devices (Code: FLL)

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.

Official Source

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