FDA 510(k) K230948, BFlex™ 2 Slim 3.8 Single-Use Bronchoscope, by Verathon Medical (Canada) Ulc
FDA 510(k) K230948, BFlex™ 2 Slim 3.8 Single-Use Bronchoscope, by Verathon Medical (Canada) Ulc
Device Classification Name: Bronchoscope (Flexible Or Rigid)
510(k) Number: K230948
Device Name: BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
Applicant: Verathon Medical (Canada) Ulc
Regulation Number: 874.4680
Classification Product Code: EOQ
Date Received: 04/04/2023
Decision Date: 05/03/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
510k Review Panel: Ear Nose & Throat
Total number of pages: 1,092
Fully redacted pages: 852
Content pages: 240
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