The following data is part of a premarket notification filed by Healthmate, Inc. with the FDA for Fluoroscan/tm By Healthmate.
| Device ID | K843920 |
| 510k Number | K843920 |
| Device Name: | FLUOROSCAN/TM BY HEALTHMATE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | HEALTHMATE, INC. 3000 DUNDEE ROAD Northbrook , IL 60062 - |
| Contact | Ken Wieselman |
| Correspondent | Ken Wieselman HEALTHMATE, INC. 3000 DUNDEE ROAD Northbrook , IL 60062 - |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-05 |
| Decision Date | 1985-02-07 |