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FDA 510(k)

breastscape v1.0

K-Number: K211431 · 2021-08-02

ApplicantOlea Medical
Decision Date2021-08-02
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

breastscape v1.0 is a medical device manufactured by Olea Medical. It received FDA 510(k) clearance on 2021-08-02 under approval number K211431. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the breastscape v1.0?

breastscape v1.0 is a medical device that received FDA 510(k) clearance on 2021-08-02. It is manufactured by Olea Medical. The 510(k) number is K211431.

When was breastscape v1.0 approved by the FDA?

breastscape v1.0 received FDA 510(k) clearance on 2021-08-02, under approval number K211431.

What company makes breastscape v1.0?

breastscape v1.0 is manufactured by Olea Medical.

What is the FDA product code for breastscape v1.0?

The FDA product code for breastscape v1.0 is QIH.

Other Devices by Olea Medical

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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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