Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL

K-Number: K082641 · 2008-11-10

Decision Date2008-11-10
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL 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 2008-11-10 under 510(k) number K082641. 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 FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL?

FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL is a medical device that received FDA 510(k) clearance on 2008-11-10. The listed applicant is Contec Medical System Co., Ltd.. The 510(k) number is K082641.

When did FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL receive FDA 510(k) clearance?

FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL received FDA 510(k) clearance on 2008-11-10, under 510(k) number K082641.

Who is the listed applicant for FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL?

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 FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL?

The FDA product code for FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL 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 Contec Medical System 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 11 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

View on FDA Database →

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

↑