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FDA 510(k)

Reusable Temperature Probe, Disposable Temperature Probe

K-Number: K223807 · 2023-08-25

Decision Date2023-08-25
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Reusable Temperature Probe, Disposable Temperature Probe is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K223807. 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 Reusable Temperature Probe, Disposable Temperature Probe?

Reusable Temperature Probe, Disposable Temperature Probe is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. The 510(k) number is K223807.

When did Reusable Temperature Probe, Disposable Temperature Probe receive FDA 510(k) clearance?

Reusable Temperature Probe, Disposable Temperature Probe received FDA 510(k) clearance on 2023-08-25, under 510(k) number K223807.

Who is the listed applicant for Reusable Temperature Probe, Disposable Temperature Probe?

The FDA 510(k) record lists Shenzhen Sino-K Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reusable Temperature Probe, Disposable Temperature Probe?

The FDA product code for Reusable Temperature Probe, Disposable Temperature Probe is FLL.

Other records listing Shenzhen Sino-K Medical Technology 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.

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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