The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Spacelabs Medical 12-lead Diagnostic Ecg Analysis Option.
| Device ID | K962970 |
| 510k Number | K962970 |
| Device Name: | SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Russ Garrison |
| Correspondent | Russ Garrison SPACELABS MEDICAL, INC. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-31 |
| Decision Date | 1997-03-25 |
| Summary: | summary |