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FDA 510(k)

N-600X WITH SPD, OXIMAX N-600X

K-Number: K083325 · 2009-03-09

ApplicantCovidien
Decision Date2009-03-09
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

N-600X WITH SPD, OXIMAX N-600X is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2009-03-09 under 510(k) number K083325. 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 N-600X WITH SPD, OXIMAX N-600X?

N-600X WITH SPD, OXIMAX N-600X is a medical device that received FDA 510(k) clearance on 2009-03-09. The listed applicant is Covidien. The 510(k) number is K083325.

When did N-600X WITH SPD, OXIMAX N-600X receive FDA 510(k) clearance?

N-600X WITH SPD, OXIMAX N-600X received FDA 510(k) clearance on 2009-03-09, under 510(k) number K083325.

Who is the listed applicant for N-600X WITH SPD, OXIMAX N-600X?

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

What is the FDA product code for N-600X WITH SPD, OXIMAX N-600X?

The FDA product code for N-600X WITH SPD, OXIMAX N-600X is DQA.

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Related Devices (Code: DQA)

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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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