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FDA 510(k)

SKEEPER

K-Number: K230613 · 2023-08-02

ApplicantSmartsound Corporation
Decision Date2023-08-02
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKEEPER is the device name listed in this FDA 510(k) record. The listed applicant is Smartsound Corporation. It received FDA 510(k) clearance on 2023-08-02 under 510(k) 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. The listed applicant is Smartsound Corporation. The 510(k) number is K230613.

When did SKEEPER receive FDA 510(k) clearance?

SKEEPER received FDA 510(k) clearance on 2023-08-02, under 510(k) number K230613.

Who is the listed applicant for SKEEPER?

The FDA 510(k) record lists Smartsound Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKEEPER?

The FDA product code for SKEEPER is DQD.

Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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