Shear Stress Therapeutics SST 3000
K-Number: K182163 · 2019-07-09
ApplicantShear Stress Therapeutics, LLC
Decision Date2019-07-09
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Shear Stress Therapeutics SST 3000 is a medical device manufactured by Shear Stress Therapeutics, LLC. It received FDA 510(k) clearance on 2019-07-09 under approval number K182163. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Shear Stress Therapeutics SST 3000?
Shear Stress Therapeutics SST 3000 is a medical device that received FDA 510(k) clearance on 2019-07-09. It is manufactured by Shear Stress Therapeutics, LLC. The 510(k) number is K182163.
When was Shear Stress Therapeutics SST 3000 approved by the FDA?
Shear Stress Therapeutics SST 3000 received FDA 510(k) clearance on 2019-07-09, under approval number K182163.
What company makes Shear Stress Therapeutics SST 3000?
Shear Stress Therapeutics SST 3000 is manufactured by Shear Stress Therapeutics, LLC.
What is the FDA product code for Shear Stress Therapeutics SST 3000?
The FDA product code for Shear Stress Therapeutics SST 3000 is IPF.
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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.