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FDA 510(k)

Checkme O2 Pulse Oximeter

K-Number: K191088 · 2019-12-02

Decision Date2019-12-02
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Checkme O2 Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Viatom Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-02 under 510(k) number K191088. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Checkme O2 Pulse Oximeter?

Checkme O2 Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Shenzhen Viatom Technology Co., Ltd.. The 510(k) number is K191088.

When did Checkme O2 Pulse Oximeter receive FDA 510(k) clearance?

Checkme O2 Pulse Oximeter received FDA 510(k) clearance on 2019-12-02, under 510(k) number K191088.

Who is the listed applicant for Checkme O2 Pulse Oximeter?

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

What is the FDA product code for Checkme O2 Pulse Oximeter?

The FDA product code for Checkme O2 Pulse Oximeter is DQA.

Other records listing Shenzhen Viatom 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: DQA)

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.