The following data is part of a premarket notification filed by R2 Corp. with the FDA for R2(tm) Ecg Cable-adaptor #'s 120-121-122.
| Device ID | K800931 |
| 510k Number | K800931 |
| Device Name: | R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122 |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | R2 CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-21 |
| Decision Date | 1980-05-23 |