The following data is part of a premarket notification filed by Auris Surgical Robotics, Inc. with the FDA for Monarch Endoscopy Platform (monarch Platform).
| Device ID | K173760 |
| 510k Number | K173760 |
| Device Name: | Monarch Endoscopy Platform (Monarch Platform) |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Auris Surgical Robotics, Inc. 125 Shoreway Road Suite D San Carlos, CA 94070 |
| Contact | Joy Sacmar |
| Correspondent | Joy Sacmar Auris Surgical Robotics, 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 | 2017-12-11 |
| Decision Date | 2018-03-22 |
| Summary: | summary |