The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Fluorospot Compact.
| Device ID | K982028 |
| 510k Number | K982028 |
| Device Name: | FLUOROSPOT COMPACT |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Malgorzata Stanek |
| Correspondent | Malgorzata Stanek SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-09 |
| Decision Date | 1998-07-14 |
| Summary: | summary |