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 |