The following data is part of a premarket notification filed by Heart Imaging Technologies, Llc with the FDA for Webpax, Model 200.
Device ID | K051325 |
510k Number | K051325 |
Device Name: | WEBPAX, MODEL 200 |
Classification | System, Image Processing, Radiological |
Applicant | HEART IMAGING TECHNOLOGIES, LLC 108 BARTON LANE Chapel Hill, NC 27516 |
Contact | Robert M Judd |
Correspondent | Robert M Judd HEART IMAGING TECHNOLOGIES, LLC 108 BARTON LANE Chapel Hill, NC 27516 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-20 |
Decision Date | 2005-06-15 |
Summary: | summary |