Second Opinion® BLE— 510(k) K243230

Substantially Equivalent

Pearl, Inc.

FDA 510(k) clearance K243230 for Second Opinion® BLE, Substantially Equivalent on 2025-05-09. Applicant: Pearl, Inc..

Clearance details

Applicant
Pearl, Inc.
Product code
Code QIH
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beverly Hills, CA, US
Download summary PDFView on FDA.gov ↗

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