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FDA 510(k)

PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D

K-Number: K090671 · 2009-06-11

ApplicantContec Medical System Co., Ltd.
Decision Date2009-06-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D is the device name listed in this FDA 510(k) record. The listed applicant is Contec Medical System Co., Ltd.. It received FDA 510(k) clearance on 2009-06-11 under 510(k) number K090671. 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 PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D?

PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D is a medical device that received FDA 510(k) clearance on 2009-06-11. The listed applicant is Contec Medical System Co., Ltd.. The 510(k) number is K090671.

When did PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D receive FDA 510(k) clearance?

PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D received FDA 510(k) clearance on 2009-06-11, under 510(k) number K090671.

Who is the listed applicant for PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D?

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

What is the FDA product code for PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D?

The FDA product code for PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D is DQA.

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Other records listing Contec Medical System Co., Ltd. as applicant

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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

View on FDA Database →

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

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