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 |