BresoDX1— 510(k) K220012

Substantially Equivalent

Bresotec, Inc.

FDA 510(k) clearance K220012 for BresoDX1, Substantially Equivalent on 2022-12-21. Applicant: Bresotec, Inc..

Clearance details

Applicant: Bresotec, Inc.
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2022-01-04
Decision date: 2022-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

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