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FDA 510(k)

Cirona 6400

K-Number: K161209 · 2016-05-31

ApplicantDevon Medical Products
Decision Date2016-05-31
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cirona 6400 is the device name listed in this FDA 510(k) record. The listed applicant is Devon Medical Products. It received FDA 510(k) clearance on 2016-05-31 under 510(k) number K161209. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cirona 6400?

Cirona 6400 is a medical device that received FDA 510(k) clearance on 2016-05-31. The listed applicant is Devon Medical Products. The 510(k) number is K161209.

When did Cirona 6400 receive FDA 510(k) clearance?

Cirona 6400 received FDA 510(k) clearance on 2016-05-31, under 510(k) number K161209.

Who is the listed applicant for Cirona 6400?

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

What is the FDA product code for Cirona 6400?

The FDA product code for Cirona 6400 is JOW.

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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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