The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Pulse Cardule (model 1859/1860 Ecg).
| Device ID | K760120 |
| 510k Number | K760120 |
| Device Name: | PULSE CARDULE (MODEL 1859/1860 ECG) |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | SPACELABS, INC. 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 | 1976-06-28 |
| Decision Date | 1976-07-20 |