FDA 510(k)

SHENZHEN MED-LINK PULSE OXIMETER PROBE

K-Number: K113727 · 2013-03-21

ApplicantShenzhen Med-Link Electronics Tech Co., Ltd.

Decision Date2013-03-21

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SHENZHEN MED-LINK PULSE OXIMETER PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2013-03-21 under 510(k) number K113727. 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 SHENZHEN MED-LINK PULSE OXIMETER PROBE?

SHENZHEN MED-LINK PULSE OXIMETER PROBE is a medical device that received FDA 510(k) clearance on 2013-03-21. The listed applicant is Shenzhen Med-Link Electronics Tech Co., Ltd.. The 510(k) number is K113727.

When did SHENZHEN MED-LINK PULSE OXIMETER PROBE receive FDA 510(k) clearance?

SHENZHEN MED-LINK PULSE OXIMETER PROBE received FDA 510(k) clearance on 2013-03-21, under 510(k) number K113727.

Who is the listed applicant for SHENZHEN MED-LINK PULSE OXIMETER PROBE?

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

What is the FDA product code for SHENZHEN MED-LINK PULSE OXIMETER PROBE?

The FDA product code for SHENZHEN MED-LINK PULSE OXIMETER PROBE is DQA.

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Related Devices (Code: DQA)

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Official Source

View on FDA Database →

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