PS System
K-Number: K211721 · 2021-12-02
ApplicantInter-Med, Inc.
Decision Date2021-12-02
Product CodeNYL
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PS System is a medical device manufactured by Inter-Med, Inc.. It received FDA 510(k) clearance on 2021-12-02 under approval number K211721. The device is classified under product code NYL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PS System?
PS System is a medical device that received FDA 510(k) clearance on 2021-12-02. It is manufactured by Inter-Med, Inc.. The 510(k) number is K211721.
When was PS System approved by the FDA?
PS System received FDA 510(k) clearance on 2021-12-02, under approval number K211721.
What company makes PS System?
PS System is manufactured by Inter-Med, Inc..
What is the FDA product code for PS System?
The FDA product code for PS System is NYL.
Other Devices by Inter-Med, Inc.
Related Devices (Code: NYL)
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.