510(k) DEN230008
- Device
- DermaSensor
- Applicant
- Dermasensor, Inc.
- 510(k) number
- DEN230008
- Product code
- QZS
- Decision
- Unknown (DENG)
- Decision date
- 2024-01-12
- Date received
- 2023-02-02
- Regulation
- 878.1830
- Classification name
- Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Cody Simmons
- Address
- 80 SW 8th St. #2000 Miami FL US 33130 33130
FDA Registration Numbers#
- 3016908271
- 3017254114
Source Documents#
510(k) summary PDF not indicated by FDA