FDA 510(k)

ARCO FP-S

K-Number: K211777 · 2021-08-13

ApplicantA.T.S. Applicazione Tecnologie Speciali S.R.L.

Decision Date2021-08-13

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ARCO FP-S is a medical device manufactured by A.T.S. Applicazione Tecnologie Speciali S.R.L.. It received FDA 510(k) clearance on 2021-08-13 under approval number K211777. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCO FP-S?

ARCO FP-S is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by A.T.S. Applicazione Tecnologie Speciali S.R.L.. The 510(k) number is K211777.

When was ARCO FP-S approved by the FDA?

ARCO FP-S received FDA 510(k) clearance on 2021-08-13, under approval number K211777.

What company makes ARCO FP-S?

ARCO FP-S is manufactured by A.T.S. Applicazione Tecnologie Speciali S.R.L..

What is the FDA product code for ARCO FP-S?

The FDA product code for ARCO FP-S is OWB.

Other Devices by A.T.S. Applicazione Tecnologie Speciali S.R.L.

K182086ARCO FP K211542PRIMO S K250282Persona C HR

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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.