The following data is part of a premarket notification filed by Spacelabs Burdick, Inc. with the FDA for Quest Exercise Stress System, Model Configuration 14.
| Device ID | K011339 |
| 510k Number | K011339 |
| Device Name: | QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SPACELABS BURDICK, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Contact | John E Greenbaum |
| Correspondent | John E Greenbaum SPACELABS BURDICK, INC. 20310 SW 48TH ST. Ft. Lauderdale, FL 33332 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-02 |
| Decision Date | 2001-08-20 |