The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Doseright.
Device ID | K012238 |
510k Number | K012238 |
Device Name: | DOSERIGHT |
Classification | System, X-ray, Tomography, Computed |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Contact | Frank Gianelli |
Correspondent | Frank Gianelli PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-17 |
Decision Date | 2001-10-01 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DOSERIGHT 76705633 4027335 Live/Registered |
William Marsh Rice University 2010-12-09 |