The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Arrhythmia Ii Editor.
| Device ID | K791776 |
| 510k Number | K791776 |
| Device Name: | ARRHYTHMIA II EDITOR |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | SPACELABS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-10 |
| Decision Date | 1979-10-02 |