SKOUT system— 510(k) K251126

Substantially Equivalent

Iterative Health

FDA 510(k) clearance K251126 for SKOUT system, Substantially Equivalent on 2025-05-09. Applicant: Iterative Health.

Clearance details

Applicant: Iterative Health
Product code: Code QNP
Advisory panel: Gastroenterology, Urology
Date received: 2025-04-11
Decision date: 2025-05-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Cambridge, MA, US

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