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FDA 510(k), K210365, Second Opinion
FDA 510(k), K210365, Second Opinion
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510(K) Number: K210365
Device Name: Second Opinion
Manufacturer: Pearl Inc.
Device Classification Name: Analyzer, Medical Image
Regulation Number: 892.2070
Classification Product Code: MYN
Date Received: 02/08/2021
Decision Date: 03/04/2022
Regulation Medical Specialty: Radiology
Device Name: Second Opinion
Manufacturer: Pearl Inc.
Device Classification Name: Analyzer, Medical Image
Regulation Number: 892.2070
Classification Product Code: MYN
Date Received: 02/08/2021
Decision Date: 03/04/2022
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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