The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Arrhythmia Net (tm) Level 2.
| Device ID | K864505 |
| 510k Number | K864505 |
| Device Name: | SPACELABS ARRHYTHMIA NET (TM) LEVEL 2 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Hans, P.e. |
| Correspondent | Hans, P.e. SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-14 |
| Decision Date | 1986-11-24 |