510(k) K133719
K133719 is an FDA 510(k) premarket notification submitted by Hamamatsu Photonics K.K. for the device "PDE-NEO". The FDA issued a decision of Substantially Equivalent on March 27, 2014. The device falls under product code IZI (System, X-Ray, Angiographic), a Class II device regulated under 21 CFR 892.1600. Hamamatsu Photonics K.K. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2014
- Date Received
- December 5, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Angiographic
- Device Class
- Class II
- Regulation Number
- 892.1600
- Review Panel
- RA
- Submission Type