FDA 510(k)

NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN

K-Number: K123581 · 2013-05-09

ApplicantCovidien, Formerly Nellcor Puritan Bennett, Inc.

Decision Date2013-05-09

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, Formerly Nellcor Puritan Bennett, Inc.. It received FDA 510(k) clearance on 2013-05-09 under 510(k) number K123581. 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 OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN?

NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN is a medical device that received FDA 510(k) clearance on 2013-05-09. The listed applicant is Covidien, Formerly Nellcor Puritan Bennett, Inc.. The 510(k) number is K123581.

When did NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN receive FDA 510(k) clearance?

NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN received FDA 510(k) clearance on 2013-05-09, under 510(k) number K123581.

Who is the listed applicant for NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN?

The FDA 510(k) record lists Covidien, Formerly Nellcor Puritan Bennett, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN?

The FDA product code for NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN is DQA.

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Related Devices (Code: DQA)

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Official Source

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