The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Arrhythmia Iii Cardule #1919.
| Device ID | K832693 |
| 510k Number | K832693 |
| Device Name: | ARRHYTHMIA III CARDULE #1919 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SPACELABS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-10 |
| Decision Date | 1983-11-07 |