FDA 510(k)

OW100S

K-Number: K231710 · 2023-09-01

Decision Date2023-09-01

Product CodePZL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OW100S is the device name listed in this FDA 510(k) record. The listed applicant is Softwave/Trt, LLC. It received FDA 510(k) clearance on 2023-09-01 under 510(k) number K231710. The device is classified under product code PZL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OW100S?

OW100S is a medical device that received FDA 510(k) clearance on 2023-09-01. The listed applicant is Softwave/Trt, LLC. The 510(k) number is K231710.

When did OW100S receive FDA 510(k) clearance?

OW100S received FDA 510(k) clearance on 2023-09-01, under 510(k) number K231710.

Who is the listed applicant for OW100S?

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

What is the FDA product code for OW100S?

The FDA product code for OW100S is PZL.

Other records listing Softwave/Trt, LLC 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.

K233937OW100S

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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.