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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 the device name listed in this FDA 510(k) record. The listed applicant is A.T.S. Applicazione Tecnologie Speciali S.R.L.. It received FDA 510(k) clearance on 2021-08-13 under 510(k) 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. The listed applicant is A.T.S. Applicazione Tecnologie Speciali S.R.L.. The 510(k) number is K211777.

When did ARCO FP-S receive FDA 510(k) clearance?

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

Who is the listed applicant for ARCO FP-S?

The FDA 510(k) record lists A.T.S. Applicazione Tecnologie Speciali S.R.L. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing A.T.S. Applicazione Tecnologie Speciali S.R.L. as applicant

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.

K250282Persona C HRK211542PRIMO SK182086ARCO FP

Related Devices (Code: OWB)

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.

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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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