Cardiac Output Computer, Mdel 9520A

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K790047 ↗

FDA Product Code

DXG

Device Class

Class II

Regulation

21 CFR Part 870.1435

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Filter (7220&7221 Mobin-Uddin Vena Cava)

  Class II

  FDA 510(k) K760152 Active Cleared 19 Jul 1976

• Model 100 Spectraview

  Class I

  FDA 510(k) K800655 Active Cleared 16 Apr 1980

• Ac Adapter:models 9525, 9526, 9527

  Class II

  FDA 510(k) K781535 Active Cleared 15 Sep 1978

• Carpentier-Edwards Flex. Annuloplasty

  Class II

  FDA 510(k) K792441 Active Cleared 17 Mar 1980

• Probe & Catheter

  Class II

  FDA 510(k) K771663 Active Cleared 20 Sep 1977

• Disposable Holder for Bioprosthesis

  Class I

  FDA 510(k) K790022 Active Cleared 15 Jan 1979

See all devices from Edwards Laboratories →

• What is the Cardiac Output Computer Mdel 9520A used for?

  The Cardiac Output Computer Mdel 9520A is designed for cardiovascular applications and is used to compute cardiac output. As a pre-programmed, single-function diagnostic computer device, its sole purpose is to perform this specific calculation in clinical settings.

• Is the Cardiac Output Computer Mdel 9520A sterile or single-use?

  The device is supplied as a non-sterile, reusable system. There is no indication of single-use designation or sterility in the provided data, meaning it is intended for multiple uses after appropriate cleaning and reprocessing in clinical environments.

• What regulatory pathway was used for the Cardiac Output Computer Mdel 9520A?

  The device received FDA 510(k) clearance under number K790047 on February 26, 1979, through a traditional submission process. It was found substantially equivalent to a predicate device and is classified as a Class II medical device.