Quinton Model 530X Ecg Data Cart

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K790739 ↗

FDA Product Code

DPS

Device Class

Class II

Regulation

21 CFR Part 870.2340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Quinton Single Lumen Catheter

  Class II

  FDA 510(k) K893188 Active Cleared 8 Jun 1989

• Stainless Steel Guide Wire

  Class II

  FDA 510(k) K831839 Active Cleared 18 Jul 1983

• Medtrack Treadmill

  Class I

  FDA 510(k) K911751 Active Cleared 29 May 1991

• Patient by-Pass

  Class I

  FDA 510(k) K771422 Active Cleared 3 Jan 1978

• Quinton Lte Electrode

  Class II

  FDA 510(k) K810563 Active Cleared 17 Mar 1981

• Model 845T Imaging/Ergometer Table

  Class I

  FDA 510(k) K781500 Active Cleared 14 Sep 1978

See all devices from Quinton, Inc. →

• What is the Quinton Model 530x ECG Data Cart used for?

  The Quinton Model 530x ECG Data Cart is specifically designed for the acquisition and analysis of electrocardiogram (ECG) data in clinical settings, providing healthcare professionals with essential cardiac monitoring capabilities.

• How is the Quinton Model 530x ECG Data Cart supplied?

  The device is supplied as a complete cart system, making it easily transportable within clinical environments while maintaining all necessary components for ECG data acquisition and analysis in one integrated unit.

• What regulatory approvals does the Quinton Model 530x ECG Data Cart have?

  The Quinton Model 530x ECG Data Cart has received FDA 510K clearance with clearance number K790739, classified under product code DPS, and was determined to be substantially equivalent to predicate devices.

• Is the Quinton Model 530x ECG Data Cart reusable or single-use?

  The device is designed for repeated use in clinical settings, as it is a cart-based system intended for ongoing ECG data acquisition and analysis rather than being disposable or single-use equipment.