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FDA 510(k)

MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES

K-Number: K101577 · 2010-12-02

Decision Date2010-12-02
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Choice Electronic Technololgy Co., Ltd.. It received FDA 510(k) clearance on 2010-12-02 under 510(k) number K101577. 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 MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES?

MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES is a medical device that received FDA 510(k) clearance on 2010-12-02. The listed applicant is Beijing Choice Electronic Technololgy Co., Ltd.. The 510(k) number is K101577.

When did MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES receive FDA 510(k) clearance?

MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES received FDA 510(k) clearance on 2010-12-02, under 510(k) number K101577.

Who is the listed applicant for MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES?

The FDA 510(k) record lists Beijing Choice Electronic Technololgy Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES?

The FDA product code for MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES is DQA.

Related Clinical Trials

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.

Other records listing Beijing Choice Electronic Technololgy 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.

View all 24 devices →

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.

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