The following data is part of a premarket notification filed by R2 Corp. with the FDA for R2 Apex-post.,ant.&post. Elect.(12 Mods).
| Device ID | K800935 |
| 510k Number | K800935 |
| Device Name: | R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS) |
| Classification | Electrode, Electrocardiograph |
| Applicant | R2 CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| 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 |