510(k) DEN170021
- Device
- SEM Scanner (Model 200)
- Applicant
- Bruin Biometrics, LLC
- 510(k) number
- DEN170021
- Product code
- QEF
- Decision
- Unknown (DENG)
- Decision date
- 2018-12-20
- Date received
- 2017-04-03
- Regulation
- 876.2100
- Classification name
- Pressure Ulcer Management Tool
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ya-Chen Tonar
- Address
- 10960 Wilshire Blvd., Suite 950 Los Angeles CA US 90024 90024
FDA Registration Numbers#
- 3009746061
- 3009769359
- 2133810
- 1000484830
- 3017102771
Source Documents#
510(k) summary PDF not indicated by FDA