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FDA 510(k)

Saige-Q

K-Number: K203517 · 2021-04-16

ApplicantDeepHealth, Inc.
Decision Date2021-04-16
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Saige-Q is a medical device manufactured by DeepHealth, Inc.. It received FDA 510(k) clearance on 2021-04-16 under approval number K203517. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Saige-Q?

Saige-Q is a medical device that received FDA 510(k) clearance on 2021-04-16. It is manufactured by DeepHealth, Inc.. The 510(k) number is K203517.

When was Saige-Q approved by the FDA?

Saige-Q received FDA 510(k) clearance on 2021-04-16, under approval number K203517.

What company makes Saige-Q?

Saige-Q is manufactured by DeepHealth, Inc..

What is the FDA product code for Saige-Q?

The FDA product code for Saige-Q is QFM.

Other Devices by DeepHealth, Inc.

K222275Saige-Density K220105Saige-Dx K243705Saige-Density (2.5.0) K243688Saige-Dx (3.1.0) K241747Saige-Dx K251873Saige-Dx

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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.

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