SKEEPER
K-Number: K230613 · 2023-08-02
ApplicantSmartsound Corporation
Decision Date2023-08-02
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SKEEPER is a medical device manufactured by Smartsound Corporation. It received FDA 510(k) clearance on 2023-08-02 under approval number K230613. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SKEEPER?
SKEEPER is a medical device that received FDA 510(k) clearance on 2023-08-02. It is manufactured by Smartsound Corporation. The 510(k) number is K230613.
When was SKEEPER approved by the FDA?
SKEEPER received FDA 510(k) clearance on 2023-08-02, under approval number K230613.
What company makes SKEEPER?
SKEEPER is manufactured by Smartsound Corporation.
What is the FDA product code for SKEEPER?
The FDA product code for SKEEPER is DQD.
Related Devices (Code: DQD)
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.