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 the device name listed in this FDA 510(k) record. The listed applicant is Alltech Medical Systems America, Inc.. It received FDA 510(k) clearance on 2017-04-10 under 510(k) 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. The listed applicant is Alltech Medical Systems America, Inc.. The 510(k) number is K163192.

When did Comfort EC710 receive FDA 510(k) clearance?

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

Who is the listed applicant for Comfort EC710?

The FDA 510(k) record lists Alltech Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comfort EC710?

The FDA product code for Comfort EC710 is LNH.

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical Systems K261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG K260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm Corporation K260746S-scan Open (100001800)Esaote, S.p.A.

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.