The following data is part of a premarket notification filed by Electro Medical Systems, Inc. with the FDA for Radx System.
| Device ID | K965203 |
| 510k Number | K965203 |
| Device Name: | RADX SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | ELECTRO MEDICAL SYSTEMS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Steven A Clarke |
| Correspondent | Steven A Clarke ELECTRO MEDICAL SYSTEMS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-26 |
| Decision Date | 1997-03-17 |
| Summary: | summary |