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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 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 2021-07-09 under 510(k) 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. The listed applicant is A.T.S. Applicazione Tecnologie Speciali S.R.L.. The 510(k) number is K211542.

When did PRIMO S receive FDA 510(k) clearance?

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

Who is the listed applicant for PRIMO 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 PRIMO S?

The FDA product code for PRIMO S is MQB.

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 HRK211777ARCO FP-SK182086ARCO FP

Related Devices (Code: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, Inc.

Official Source

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