510(k) DEN230003
- Device
- Viz HCM
- Applicant
- Viz. Ai, Inc.
- 510(k) number
- DEN230003
- Product code
- QXO
- Decision
- Unknown (DENG)
- Decision date
- 2023-08-03
- Date received
- 2023-01-10
- Regulation
- 870.2380
- Classification name
- Cardiovascular Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gregory Ramina
- Address
- 201 Mission St., 12th Floor San Francisco CA US 94105 94105
FDA Registration Numbers#
- 3014665798
- 3014678441
Source Documents#
510(k) summary PDF not indicated by FDA