510(k) K231473
- Device
- Monarch Bronchoscope
- Applicant
- Auris Health, Inc., A Johnson and Johnson Family Company
- 510(k) number
- K231473
- Product code
- QNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-28
- Date received
- 2023-05-22
- Regulation
- 874.4680
- Classification name
- Reprocessed Bronchoscope
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Somi Ekwealor
- Address
- 150 Shoreline Dr. Redwood CA US 94065 94065
FDA Registration Numbers#
- 3011024991
- 3014246639
- 3011276773
- 3023460764
- 2183744
- 3009888344
- 2030624
- 3017425975
Source Documents#
Other 510(k) Records For Product Code QNW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203614 | Monarch Bronchoscope | Auris Health, Inc., A Johnson and Johnson Family Company | 2021-03-11 |