Monarch Bronchoscope— 510(k) K203614
Substantially EquivalentAuris Health, Inc., A Johnson and Johnson Family Company
FDA 510(k) clearance K203614 for Monarch Bronchoscope, Substantially Equivalent on 2021-03-11. Applicant: Auris Health, Inc., A Johnson and Johnson Family Company. Device class: 2.
Clearance details
- Applicant
- Auris Health, Inc., A Johnson and Johnson Family Company
- Product code
- Code QNW
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood, CA, US
Recent devices under product code QNW
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