PROSTATE MECHANICAL IMAGER
FDA 510(k) clearance DEN100016 · decided 2012-04-27
Clearance details
- K-number
- DEN100016
- Device name
- PROSTATE MECHANICAL IMAGER
- Applicant
- Artann Laboratories, Inc.
- Decision
- Unknown
- Date received
- 2010-05-21
- Decision date
- 2012-04-27
- Days to decision
- 707 days
- Clearance type
- Post-NSE
- Product code
- OQT
- Device class
- 2
- Regulation number
- 876.2050
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Washington D.C., DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.