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FDA 510(k)

PRIMO S

K-Number: K211542 · 2021-07-09

ApplicantA.T.S. Applicazione Tecnologie Speciali S.R.L.
Decision Date2021-07-09
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRIMO S is a medical device manufactured by A.T.S. Applicazione Tecnologie Speciali S.R.L.. It received FDA 510(k) clearance on 2021-07-09 under approval number K211542. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMO S?

PRIMO S is a medical device that received FDA 510(k) clearance on 2021-07-09. It is manufactured by A.T.S. Applicazione Tecnologie Speciali S.R.L.. The 510(k) number is K211542.

When was PRIMO S approved by the FDA?

PRIMO S received FDA 510(k) clearance on 2021-07-09, under approval number K211542.

What company makes PRIMO S?

PRIMO S is manufactured by A.T.S. Applicazione Tecnologie Speciali S.R.L..

What is the FDA product code for PRIMO S?

The FDA product code for PRIMO S is MQB.

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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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