The following data is part of a premarket notification filed by Amr Co. with the FDA for Generator, R-wave.
| Device ID | K790213 |
| 510k Number | K790213 |
| Device Name: | GENERATOR, R-WAVE |
| Classification | Synchronizer, Electrocardiograph, Nuclear |
| Applicant | AMR CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYY |
| CFR Regulation Number | 892.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-30 |
| Decision Date | 1979-03-22 |