The following data is part of a premarket notification filed by Siemens Corp. with the FDA for Portaray.
Device ID | K792535 |
510k Number | K792535 |
Device Name: | PORTARAY |
Classification | Unit, X-ray, Intraoral |
Applicant | SIEMENS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EAP |
CFR Regulation Number | 872.1810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-07 |
Decision Date | 1980-01-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PORTARAY 86400937 not registered Dead/Abandoned |
PortaVision Medical LLC 2014-09-20 |