The following data is part of a premarket notification filed by Radiation Measurements, Inc. with the FDA for Rmi Respiratory Gating System Model 301.
| Device ID | K854976 |
| 510k Number | K854976 |
| Device Name: | RMI RESPIRATORY GATING SYSTEM MODEL 301 |
| Classification | Synchronizer, Ecg / Respirator, Radiographic |
| Applicant | RADIATION MEASUREMENTS, INC. P.O. BOX 327 7617 DONNA DRIVE Middleton, WI 53562 |
| Contact | Michele J Wolff |
| Correspondent | Michele J Wolff RADIATION MEASUREMENTS, INC. P.O. BOX 327 7617 DONNA DRIVE Middleton, WI 53562 |
| Product Code | IXO |
| CFR Regulation Number | 892.1970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-12 |
| Decision Date | 1986-05-07 |