The following data is part of a premarket notification filed by Gauss Surgical, Inc. with the FDA for Triton Canister System.
| Device ID | K142801 |
| 510k Number | K142801 |
| Device Name: | Triton Canister 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 | Peggy Mclaughlin |
| Correspondent | Peggy Mclaughlin 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 | 2014-09-29 |
| Decision Date | 2015-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859506006135 | K142801 | 000 |
| 00859506006128 | K142801 | 000 |
| 10859506006132 | K142801 | 000 |