The following data is part of a premarket notification filed by Auris Health, Inc. with the FDA for Monarch Platform.
| Device ID | K193534 |
| 510k Number | K193534 |
| Device Name: | Monarch Platform |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Auris Health, Inc. 150 Shoreline Drive Redwood City, CA 94065 |
| Contact | Anna Libman |
| Correspondent | Anna Libman Auris Health, Inc. 150 Shoreline Drive Redwood City, CA 94065 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-20 |
| Decision Date | 2020-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B623MBR000211A0 | K193534 | 000 |
| B634MBR000211A1 | K193534 | 000 |
| 20810068810862 | K193534 | 000 |