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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 the device name listed in this FDA 510(k) record. The listed applicant is Pearl, Inc.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) 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. The listed applicant is Pearl, Inc.. The 510(k) number is K242522.

When did Second Opinion CC receive FDA 510(k) clearance?

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

Who is the listed applicant for Second Opinion CC?

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

What is the FDA product code for Second Opinion CC?

The FDA product code for Second Opinion CC is MYN.

Other records listing Pearl, 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

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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