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FDA 510(k)

NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM

K-Number: K120773 · 2012-07-10

ApplicantCovidien, LLC
Decision Date2012-07-10
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2012-07-10 under 510(k) number K120773. 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 NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM?

NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2012-07-10. The listed applicant is Covidien, LLC. The 510(k) number is K120773.

When did NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM receive FDA 510(k) clearance?

NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM received FDA 510(k) clearance on 2012-07-10, under 510(k) number K120773.

Who is the listed applicant for NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM?

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

What is the FDA product code for NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM?

The FDA product code for NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM 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 Covidien, LLC 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.

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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.

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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