510(k) DEN130015
DEN130015 is an FDA 510(k) premarket notification submitted by Gauss Surgical, Inc., for the device "PIXEL 3 SYSTEM". The FDA issued a decision of De Novo Granted on May 9, 2014. The device falls under product code PBZ (Image Processing Device For Estimation Of External Blood Loss), a Class II device regulated under 21 CFR 880.2750. Gauss Surgical, Inc., has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 9, 2014
- Date Received
- February 4, 2013
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Image Processing Device For Estimation Of External Blood Loss
- Device Class
- Class II
- Regulation Number
- 880.2750
- Review Panel
- SU
- Submission Type
An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images.