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

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 a medical device manufactured by Devon Medical Products. It received FDA 510(k) clearance on 2016-05-31 under approval 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. It is manufactured by Devon Medical Products. The 510(k) number is K161209.

When was Cirona 6400 approved by the FDA?

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

What company makes Cirona 6400?

Cirona 6400 is manufactured by Devon Medical Products.

What is the FDA product code for Cirona 6400?

The FDA product code for Cirona 6400 is JOW.

Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K161105Reprocessed Compression GarmentsCovidien K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP K150980Venous Assist SystemDaesung Maref Co., Ltd.

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.

↑