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FDA 510(k)

DeepLook PRECISE

K-Number: K202084 · 2021-04-09

ApplicantDeeplook, Inc.
Decision Date2021-04-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DeepLook PRECISE is the device name listed in this FDA 510(k) record. The listed applicant is Deeplook, Inc.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K202084. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepLook PRECISE?

DeepLook PRECISE is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Deeplook, Inc.. The 510(k) number is K202084.

When did DeepLook PRECISE receive FDA 510(k) clearance?

DeepLook PRECISE received FDA 510(k) clearance on 2021-04-09, under 510(k) number K202084.

Who is the listed applicant for DeepLook PRECISE?

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

What is the FDA product code for DeepLook PRECISE?

The FDA product code for DeepLook PRECISE is LLZ.

Related Devices (Code: LLZ)

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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