SilentZPro 2.0
K-Number: K220688 · 2022-12-02
ApplicantShinrin-Yoku Traders, LLC
Decision Date2022-12-02
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SilentZPro 2.0 is a medical device manufactured by Shinrin-Yoku Traders, LLC. It received FDA 510(k) clearance on 2022-12-02 under approval number K220688. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SilentZPro 2.0?
SilentZPro 2.0 is a medical device that received FDA 510(k) clearance on 2022-12-02. It is manufactured by Shinrin-Yoku Traders, LLC. The 510(k) number is K220688.
When was SilentZPro 2.0 approved by the FDA?
SilentZPro 2.0 received FDA 510(k) clearance on 2022-12-02, under approval number K220688.
What company makes SilentZPro 2.0?
SilentZPro 2.0 is manufactured by Shinrin-Yoku Traders, LLC.
What is the FDA product code for SilentZPro 2.0?
The FDA product code for SilentZPro 2.0 is LRK.
Related Devices (Code: LRK)
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.