The following data is part of a premarket notification filed by Darox Corp. with the FDA for R2 Pace Pad, Model 480.
| Device ID | K895729 |
| 510k Number | K895729 |
| Device Name: | R2 PACE PAD, MODEL 480 |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | DAROX CORP. 5731 WEST HOWARD AVE. Niles, IL 60648 |
| Contact | William J Smirles |
| Correspondent | William J Smirles DAROX CORP. 5731 WEST HOWARD AVE. Niles, IL 60648 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1989-10-12 |