The following data is part of a premarket notification filed by Spacelabs Medical, Inc. with the FDA for Quest Exercise Stress System (quest), Version 3.52.
| Device ID | K021097 |
| 510k Number | K021097 |
| Device Name: | QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SPACELABS MEDICAL, INC. 1730 PENNSYLVANIA AVE. NW Washington, DC 20006 |
| Contact | Edward M Basile |
| Correspondent | Edward M Basile SPACELABS MEDICAL, INC. 1730 PENNSYLVANIA AVE. NW Washington, DC 20006 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-04 |
| Decision Date | 2002-06-28 |
| Summary: | summary |