The following data is part of a premarket notification filed by Lunar Radiation Corp. with the FDA for Wisconsin Heart Rate Monitor.
| Device ID | K802182 |
| 510k Number | K802182 |
| Device Name: | WISCONSIN HEART RATE MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | LUNAR RADIATION CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-09 |
| Decision Date | 1980-10-31 |