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FDA 510(k)

Resascope RS-01/B

K-Number: K201113 · 2020-12-21

ApplicantAdvanced Medical Systems Group Srl
Decision Date2020-12-21
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Resascope RS-01/B is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Medical Systems Group Srl. It received FDA 510(k) clearance on 2020-12-21 under 510(k) number K201113. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resascope RS-01/B?

Resascope RS-01/B is a medical device that received FDA 510(k) clearance on 2020-12-21. The listed applicant is Advanced Medical Systems Group Srl. The 510(k) number is K201113.

When did Resascope RS-01/B receive FDA 510(k) clearance?

Resascope RS-01/B received FDA 510(k) clearance on 2020-12-21, under 510(k) number K201113.

Who is the listed applicant for Resascope RS-01/B?

The FDA 510(k) record lists Advanced Medical Systems Group Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Resascope RS-01/B?

The FDA product code for Resascope RS-01/B is HRX.

Related Devices (Code: HRX)

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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