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FDA 510(k)

Comfort EC710

K-Number: K163192 · 2017-04-10

ApplicantAlltech Medical Systems America, Inc.
Decision Date2017-04-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Comfort EC710 is a medical device manufactured by Alltech Medical Systems America, Inc.. It received FDA 510(k) clearance on 2017-04-10 under approval number K163192. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comfort EC710?

Comfort EC710 is a medical device that received FDA 510(k) clearance on 2017-04-10. It is manufactured by Alltech Medical Systems America, Inc.. The 510(k) number is K163192.

When was Comfort EC710 approved by the FDA?

Comfort EC710 received FDA 510(k) clearance on 2017-04-10, under approval number K163192.

What company makes Comfort EC710?

Comfort EC710 is manufactured by Alltech Medical Systems America, Inc..

What is the FDA product code for Comfort EC710?

The FDA product code for Comfort EC710 is LNH.

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Official Source

View on FDA Database →

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