510(k) DEN130015
- Device
- PIXEL 3 SYSTEM
- Applicant
- Gauss Surgical, Inc.,
- 510(k) number
- DEN130015
- Product code
- PBZ
- Decision
- Unknown (DENG)
- Decision date
- 2014-05-09
- Date received
- 2013-02-04
- Regulation
- 880.2750
- Classification name
- Image Processing Device For Estimation Of External Blood Loss
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- PEGGY MCLAUGHLIN
- Address
- 334 State St., Suite 201 Los Altos CA US 94022 94022
FDA Registration Numbers#
- 3015967359
- 3010141593
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PBZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252282 | SurgiCount+ System | Stryker Instruments | 2026-03-16 |
| K232250 | SurgiCount+ System | Stryker Instruments | 2024-01-11 |
| K163507 | Triton Sponge System | Gauss Surgical, Inc., | 2017-04-25 |
| K160338 | Triton System | Gauss Surgical, Inc., | 2016-08-05 |
| K142801 | Triton Canister System | Gauss Surgical, Inc., | 2015-03-12 |