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 |