The following data is part of a premarket notification filed by R2 Corp. with the FDA for R2(tm) Ecg Electrode Set-#'s305-306 Etc..
Device ID | K800930 |
510k Number | K800930 |
Device Name: | R2(TM) ECG ELECTRODE SET-#'S305-306 ETC. |
Classification | Electrode, Electrocardiograph |
Applicant | R2 CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-21 |
Decision Date | 1980-05-23 |