The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Heartrate Plus Ecg Cardule #1918.
| Device ID | K830306 |
| 510k Number | K830306 |
| Device Name: | HEARTRATE PLUS ECG CARDULE #1918 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-31 |
| Decision Date | 1983-03-17 |