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FDA 510(k)

CHARMCARE TABLETOP PULSE OXIMETER

K-Number: K092641 · 2010-10-21

ApplicantCharmcare Co., Ltd.
Decision Date2010-10-21
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHARMCARE TABLETOP PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Charmcare Co., Ltd.. It received FDA 510(k) clearance on 2010-10-21 under 510(k) number K092641. 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 CHARMCARE TABLETOP PULSE OXIMETER?

CHARMCARE TABLETOP PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2010-10-21. The listed applicant is Charmcare Co., Ltd.. The 510(k) number is K092641.

When did CHARMCARE TABLETOP PULSE OXIMETER receive FDA 510(k) clearance?

CHARMCARE TABLETOP PULSE OXIMETER received FDA 510(k) clearance on 2010-10-21, under 510(k) number K092641.

Who is the listed applicant for CHARMCARE TABLETOP PULSE OXIMETER?

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

What is the FDA product code for CHARMCARE TABLETOP PULSE OXIMETER?

The FDA product code for CHARMCARE TABLETOP PULSE OXIMETER is DQA.

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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.

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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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