KENZ-ECG 102

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

510(k) Number

K863965 ↗

FDA Product Code

DXK

Device Class

Class II

Regulation

21 CFR Part 870.2330

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Osteogram Bone Densitometer

  Class II

  FDA 510(k) K984285 Active Cleared 19 May 1999

• Compumed Pulmonary Function Analyzer Model 307B

  Class II

  FDA 510(k) K854626 Active Cleared 28 Feb 1986

• Compumed Dicon Client

  Class I

  FDA 510(k) K955708 Active Cleared 1 Mar 1996

• Computer ECG Terminal

  Class II

  FDA 510(k) K802272 Active Cleared 26 Sep 1980

• Computer ECG Terminal

  Class II

  FDA 510(k) K771648 Active Cleared 20 Sep 1977

• What is the KENZ-ECG 102 device used for?

  The KENZ-ECG 102 is an echocardiograph device designed for cardiovascular applications. It uses ultrasound technology to produce images of the heart, allowing clinicians to assess cardiac structure and function.

• Is the KENZ-ECG 102 a single-use or reusable device?

  The device data does not specify whether the KENZ-ECG 102 is single-use or reusable. No information regarding sterility or reuse instructions is provided in the available documentation.

• What regulatory approvals does the KENZ-ECG 102 have?

  The KENZ-ECG 102 received FDA 510(k) clearance on December 22, 1986. It is classified as a Class II medical device with product code DXK and was determined to be substantially equivalent to predicate devices.

• What are the specifications of the KENZ-ECG 102?

  The KENZ-ECG 102 is an echocardiograph device that produces images of the heart using ultrasound technology. It is manufactured by Compumed, Inc. and has the K number K863965. No specific measurements or technical specifications beyond its function are provided.