The following data is part of a premarket notification filed by Theta Systems, Inc. with the FDA for Patient Dose Monitor.
| Device ID | K912249 |
| 510k Number | K912249 |
| Device Name: | PATIENT DOSE MONITOR |
| Classification | Generator, High Voltage, X-ray, Therapeutic |
| Applicant | THETA SYSTEMS, INC. 6425 ANDERSON WAY Melbourne, FL 32940 |
| Contact | Kevin Russell |
| Correspondent | Kevin Russell THETA SYSTEMS, INC. 6425 ANDERSON WAY Melbourne, FL 32940 |
| Product Code | KPZ |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-21 |
| Decision Date | 1991-08-30 |