The following data is part of a premarket notification filed by R2 Corp. with the FDA for R2 Plate Type Cable-adaptor #s 175,176.
| Device ID | K800937 |
| 510k Number | K800937 |
| Device Name: | R2 PLATE TYPE CABLE-ADAPTOR #S 175,176 |
| Classification | Dc-defibrillator, Low-energy, (including Paddles) |
| Applicant | R2 CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LDD |
| CFR Regulation Number | 870.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-21 |
| Decision Date | 1980-05-23 |