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FDA 510(k)

Second Opinion CC

K-Number: K242522 · 2025-01-16

ApplicantPearl, Inc.
Decision Date2025-01-16
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Second Opinion CC is a medical device manufactured by Pearl, Inc.. It received FDA 510(k) clearance on 2025-01-16 under approval number K242522. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Second Opinion CC?

Second Opinion CC is a medical device that received FDA 510(k) clearance on 2025-01-16. It is manufactured by Pearl, Inc.. The 510(k) number is K242522.

When was Second Opinion CC approved by the FDA?

Second Opinion CC received FDA 510(k) clearance on 2025-01-16, under approval number K242522.

What company makes Second Opinion CC?

Second Opinion CC is manufactured by Pearl, Inc..

What is the FDA product code for Second Opinion CC?

The FDA product code for Second Opinion CC is MYN.

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Other Devices by Pearl, Inc.

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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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