QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14— 510(k) K011339

Name: FDA 510(k) clearance K011339
Creator: U.S. Food and Drug Administration
Published: 2001-08-20

Substantially Equivalent

Spacelabs Burdick, Inc.

FDA 510(k) clearance K011339 for QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14, Substantially Equivalent on 2001-08-20. Applicant: Spacelabs Burdick, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs Burdick, Inc.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2001-05-02
Decision date: 2001-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South West Ranches, FL, US

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Recent devices under product code DSI

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K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)2025-07-29
K240177 — Zio AT® device (A100A1001)2024-10-30
K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System2023-10-06
K231276 — SmartCardia 7L Platform2023-08-30

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.