The following data is part of a premarket notification filed by Electromed Intl., Ltd. with the FDA for Infant Caridac Monitor.
| Device ID | K812674 |
| 510k Number | K812674 |
| Device Name: | INFANT CARIDAC MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | ELECTROMED INTL., LTD. 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 | 1981-09-22 |
| Decision Date | 1981-10-13 |