The following data is part of a premarket notification filed by Auris Health, Inc. with the FDA for Monarch Platform.
| Device ID | K211493 |
| 510k Number | K211493 |
| Device Name: | Monarch Platform |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Auris Health, Inc. 150 Shoreline Drive Redwood, CA 94065 |
| Contact | Shikha Gola |
| Correspondent | Shikha Gola Auris Health, Inc. 150 Shoreline Drive Redwood, CA 94065 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-13 |
| Decision Date | 2021-07-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B634MON0007091 | K211493 | 000 |
| 10810068810506 | K211493 | 000 |
| 10810068810490 | K211493 | 000 |
| 10810068810483 | K211493 | 000 |
| 10810068810476 | K211493 | 000 |
| 10810068810797 | K211493 | 000 |
| 10810068810780 | K211493 | 000 |
| 10810068810773 | K211493 | 000 |
| 10810068810766 | K211493 | 000 |