SmarTemp X1— 510(k) K190930

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K190930 for SmarTemp X1, Substantially Equivalent on 2019-09-05. Applicant: Parkell, Inc..

Clearance details

Applicant: Parkell, Inc.
Product code: Code EBG
Advisory panel: Dental
Date received: 2019-04-10
Decision date: 2019-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgewood, NY, US

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