The following data is part of a premarket notification filed by Ross Research, Inc. with the FDA for Noninvasive Temporary Pacemaker.
| Device ID | K822246 |
| 510k Number | K822246 |
| Device Name: | NONINVASIVE TEMPORARY PACEMAKER |
| Classification | Pacemaker, Cardiac, External Transcutaneous (non-invasive) |
| Applicant | ROSS RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRO |
| CFR Regulation Number | 870.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-29 |
| Decision Date | 1982-08-06 |