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FDA 510(k)

ReadeR, VieweR, QuickScan PSP

K-Number: K160386 · 2016-03-10

ApplicantTrident S.R.L
Decision Date2016-03-10
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ReadeR, VieweR, QuickScan PSP is the device name listed in this FDA 510(k) record. The listed applicant is Trident S.R.L. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K160386. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReadeR, VieweR, QuickScan PSP?

ReadeR, VieweR, QuickScan PSP is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Trident S.R.L. The 510(k) number is K160386.

When did ReadeR, VieweR, QuickScan PSP receive FDA 510(k) clearance?

ReadeR, VieweR, QuickScan PSP received FDA 510(k) clearance on 2016-03-10, under 510(k) number K160386.

Who is the listed applicant for ReadeR, VieweR, QuickScan PSP?

The FDA 510(k) record lists Trident S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ReadeR, VieweR, QuickScan PSP?

The FDA product code for ReadeR, VieweR, QuickScan PSP is MUH.

Other records listing Trident S.R.L as applicant

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Related Devices (Code: MUH)

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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