FDA 510(k)

Saige-Q

K-Number: K203517 · 2021-04-16

Decision Date2021-04-16

Product CodeQFM

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Saige-Q is the device name listed in this FDA 510(k) record. The listed applicant is DeepHealth, Inc.. It received FDA 510(k) clearance on 2021-04-16 under 510(k) 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. The listed applicant is DeepHealth, Inc.. The 510(k) number is K203517.

When did Saige-Q receive FDA 510(k) clearance?

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

Who is the listed applicant for Saige-Q?

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

What is the FDA product code for Saige-Q?

The FDA product code for Saige-Q is QFM.

Other records listing DeepHealth, Inc. as applicant

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.