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FDA 510(k)

Sterile Disposable Temperature Probe

K-Number: K212945 · 2022-03-01

ApplicantShenzhen Envisen Industry Co., Ltd.
Decision Date2022-03-01
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Disposable Temperature Probe is a medical device manufactured by Shenzhen Envisen Industry Co., Ltd.. It received FDA 510(k) clearance on 2022-03-01 under approval number K212945. 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 Sterile Disposable Temperature Probe?

Sterile Disposable Temperature Probe is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Shenzhen Envisen Industry Co., Ltd.. The 510(k) number is K212945.

When was Sterile Disposable Temperature Probe approved by the FDA?

Sterile Disposable Temperature Probe received FDA 510(k) clearance on 2022-03-01, under approval number K212945.

What company makes Sterile Disposable Temperature Probe?

Sterile Disposable Temperature Probe is manufactured by Shenzhen Envisen Industry Co., Ltd..

What is the FDA product code for Sterile Disposable Temperature Probe?

The FDA product code for Sterile Disposable Temperature Probe is FLL.

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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.

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