The following data is part of a premarket notification filed by Lifecare Imaging Intl., Ltd. with the FDA for Vfss Imager, Model Sis-300.
| Device ID | K000987 |
| 510k Number | K000987 |
| Device Name: | VFSS IMAGER, MODEL SIS-300 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | LIFECARE IMAGING INTL., LTD. 8411 PYOTT RD. Lake In The Hills, IL 60102 |
| Contact | Richard A Adams |
| Correspondent | Richard A Adams LIFECARE IMAGING INTL., LTD. 8411 PYOTT RD. Lake In The Hills, IL 60102 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-27 |
| Decision Date | 2000-06-01 |