Osstell IDx— 510(k) K142358

Substantially Equivalent

Osstell AB

FDA 510(k) clearance K142358 for Osstell IDx, Substantially Equivalent on 2015-02-19. Applicant: Osstell AB.

Clearance details

Applicant: Osstell AB
Product code: Code EKX
Advisory panel: Dental
Date received: 2014-08-25
Decision date: 2015-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gothenburg, SE

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