FDA 510(k)

D²RS and D²RS 9090

K-Number: K213479 · 2021-12-23

Decision Date2021-12-23

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

D²RS and D²RS 9090 is the device name listed in this FDA 510(k) record. The listed applicant is Stephanix. It received FDA 510(k) clearance on 2021-12-23 under 510(k) number K213479. 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 D²RS and D²RS 9090?

D²RS and D²RS 9090 is a medical device that received FDA 510(k) clearance on 2021-12-23. The listed applicant is Stephanix. The 510(k) number is K213479.

When did D²RS and D²RS 9090 receive FDA 510(k) clearance?

D²RS and D²RS 9090 received FDA 510(k) clearance on 2021-12-23, under 510(k) number K213479.

Who is the listed applicant for D²RS and D²RS 9090?

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

What is the FDA product code for D²RS and D²RS 9090?

The FDA product code for D²RS and D²RS 9090 is OWB.

Other records listing Stephanix 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.

K221335D²RS and D²RS 9090 K212515MOVIX DReamy

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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.