510(k) DEN100016
- Device
- PROSTATE MECHANICAL IMAGER
- Applicant
- Artann Laboratories, Inc.
- 510(k) number
- DEN100016
- Product code
- OQT
- Decision
- Unknown (DENG)
- Decision date
- 2012-04-27
- Date received
- 2010-05-21
- Regulation
- 876.2050
- Classification name
- Prostate Lesion, Documentation, System
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- GERARD J PRUD'HOMME
- Address
- 555 13th St., NW Columbia Sq. Washington D.C. DC US 20004 20004
Source Documents
510(k) summary PDF not indicated by FDA