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FDA 510(k)

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

K-Number: K223446 · 2023-01-18

ApplicantSignifier Medical Technologies, Ltd.
Decision Date2023-01-18
Product CodeQNO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is a medical device manufactured by Signifier Medical Technologies, Ltd.. It received FDA 510(k) clearance on 2023-01-18 under approval number K223446. The device is classified under product code QNO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is a medical device that received FDA 510(k) clearance on 2023-01-18. It is manufactured by Signifier Medical Technologies, Ltd.. The 510(k) number is K223446.

When was eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) approved by the FDA?

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) received FDA 510(k) clearance on 2023-01-18, under approval number K223446.

What company makes eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is manufactured by Signifier Medical Technologies, Ltd..

What is the FDA product code for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)?

The FDA product code for eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) is QNO.

Related Clinical Trials

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Related PubMed Literature

PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025) PMID: 40075149 Systematic review and meta-analysis on fully automated digital cognitive behavioral therapy for insomnia. NPJ digital medicine (2025)

Other Devices by Signifier Medical Technologies, Ltd.

K240328eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)

Related Devices (Code: QNO)

DEN200018eXciteOSA with remote and eXciteOSA without remoteSignifier Medical Technologies K240328eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)Signifier Medical Technologies, Ltd.

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.

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