The following data is part of a premarket notification filed by Auris Health Inc., A Johnson And Johnson Family Company with the FDA for Monarch Bronchoscope.
| Device ID | K203614 |
| 510k Number | K203614 |
| Device Name: | Monarch Bronchoscope |
| Classification | Reprocessed Bronchoscope |
| Applicant | Auris Health Inc., A Johnson And Johnson Family Company 150 Shoreline Drive Redwood City, CA 94065 |
| Contact | Somi Ekwealor |
| Correspondent | Somi Ekwealor Auris Health Inc., A Johnson And Johnson Family Company 150 Shoreline Drive Redwood City, CA 94065 |
| Product Code | QNW |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-10 |
| Decision Date | 2021-03-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B634MBR000211B1 | K203614 | 000 |