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FDA 510(k)

OW100S

K-Number: K233937 · 2024-07-09

ApplicantSoftwave/Trt, LLC
Decision Date2024-07-09
Product CodePZL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OW100S is a medical device manufactured by Softwave/Trt, LLC. It received FDA 510(k) clearance on 2024-07-09 under approval number K233937. 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 2024-07-09. It is manufactured by Softwave/Trt, LLC. The 510(k) number is K233937.

When was OW100S approved by the FDA?

OW100S received FDA 510(k) clearance on 2024-07-09, under approval number K233937.

What company makes OW100S?

OW100S is manufactured by Softwave/Trt, LLC.

What is the FDA product code for OW100S?

The FDA product code for OW100S is PZL.

Other Devices by Softwave/Trt, LLC

K231710OW100S

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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