FDA 510(k)

OW100S (model OW100S-US)

Numéro K : K213120 · 2022-10-12

DemandeurTissue Regeneration Technologies, LLC Dba AS Softwave Trt

Date de décision2022-10-12

Code produitISA

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

OW100S (model OW100S-US) is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K213120. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the OW100S (model OW100S-US)?

OW100S (model OW100S-US) is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. The 510(k) number is K213120.

When did OW100S (model OW100S-US) receive FDA 510(k) clearance?

OW100S (model OW100S-US) received FDA 510(k) clearance on 2022-10-12, under 510(k) number K213120.

Who is the listed applicant for OW100S (model OW100S-US)?

The FDA 510(k) record lists Tissue Regeneration Technologies, LLC Dba AS Softwave Trt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OW100S (model OW100S-US)?

The FDA product code for OW100S (model OW100S-US) is ISA.

Essais cliniques associés

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Dispositifs connexes (Code : ISA)

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Source officielle

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