Quest Exercise Stress System
FDA 510(k) K952417 · Burdick, Inc.
510(k) numberK952417
Submission
- Device name
- Quest Exercise Stress System
- Applicant
- Burdick, Inc.
Miltoon, WI, US - Received
- May 23, 1995
- Decision date
- May 22, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K942565 | Altair-Disc RecorderDQK · Traditional | 12/05/1994SE |
| K941351 | Burdick PRO2 OximeterDQA · Traditional | 10/13/1994SE |
| K942438 | Altair 6100 Cassette RecorderDSH · Traditional | 08/05/1994SE |
| K904032 | Elite II ElectrocardiographLOS · Traditional | 07/24/1991SE |
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Questions and answers
When was Quest Exercise Stress System cleared by the FDA?
Quest Exercise Stress System (K952417) received a 510(k) decision of Substantially Equivalent on May 22, 1996, 365 days after the submission was received.
What is the product code of K952417?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.