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FDA 510(k)

Handheld Pulse Oximeter

K-Number: K213431 · 2023-02-26

Decision Date2023-02-26
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Handheld Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Witleaf Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2023-02-26 under 510(k) number K213431. 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 Handheld Pulse Oximeter?

Handheld Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2023-02-26. The listed applicant is Shenzhen Witleaf Medical Electronics Co., Ltd.. The 510(k) number is K213431.

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

Handheld Pulse Oximeter received FDA 510(k) clearance on 2023-02-26, under 510(k) number K213431.

Who is the listed applicant for Handheld Pulse Oximeter?

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

What is the FDA product code for Handheld Pulse Oximeter?

The FDA product code for Handheld Pulse Oximeter is DQA.

Other records listing Shenzhen Witleaf Medical Electronics 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.