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FDA 510(k)

Disposable Temperature Probe

K-Number: K181967 · 2018-12-10

Decision Date2018-12-10
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Temperature Probe is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Launch Electrical Co., Ltd.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K181967. 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 Disposable Temperature Probe?

Disposable Temperature Probe is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Shenzhen Launch Electrical Co., Ltd.. The 510(k) number is K181967.

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

Disposable Temperature Probe received FDA 510(k) clearance on 2018-12-10, under 510(k) number K181967.

Who is the listed applicant for Disposable Temperature Probe?

The FDA 510(k) record lists Shenzhen Launch Electrical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Temperature Probe?

The FDA product code for Disposable Temperature Probe is FLL.

Other records listing Shenzhen Launch Electrical 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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