The following data is part of a premarket notification filed by Advanced Radiation Measurements, Inc. with the FDA for Arm Radiation Beam Scanner.
| Device ID | K933558 |
| 510k Number | K933558 |
| Device Name: | ARM RADIATION BEAM SCANNER |
| Classification | Accelerator, Linear, Medical |
| Applicant | ADVANCED RADIATION MEASUREMENTS, INC. 601 N.E. EMERSON ST. Port St. Lucie, FL 34983 |
| Contact | Daniel Navarro |
| Correspondent | Daniel Navarro ADVANCED RADIATION MEASUREMENTS, INC. 601 N.E. EMERSON ST. Port St. Lucie, FL 34983 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-21 |
| Decision Date | 1994-03-16 |