Orthopantomograph OP300— 510(k) K163423

Substantially Equivalent

Palodex Group OY

FDA 510(k) clearance K163423 for Orthopantomograph OP300, Substantially Equivalent on 2017-08-31. Applicant: Palodex Group OY.

Clearance details

Applicant: Palodex Group OY
Product code: Code OAS
Advisory panel: Radiology
Date received: 2016-12-06
Decision date: 2017-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuusula, FI

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