The following data is part of a premarket notification filed by Gauss Surgical Inc. with the FDA for Triton System.
| Device ID | K160338 |
| 510k Number | K160338 |
| Device Name: | Triton System |
| Classification | Image Processing Device For Estimation Of External Blood Loss |
| Applicant | GAUSS SURGICAL INC. 334 STATE STREET SUITE 201 Los Altos, CA 94022 |
| Contact | Artie Kaushik |
| Correspondent | Artie Kaushik GAUSS SURGICAL INC. 334 STATE STREET SUITE 201 Los Altos, CA 94022 |
| Product Code | PBZ |
| CFR Regulation Number | 880.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-08-05 |
| Summary: | summary |