Bridge III Receiver

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K010794 ↗

FDA Product Code

DXH

FDA applicant

Meridian Medical Technologies , Ltd.

Device Class

Class II

Regulation

21 CFR Part 870.2920

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Telepress III Blood Pressure Monitor, Model TPIII

  Class II

  FDA 510(k) K011058 Active Cleared 23 Oct 2001

• Cardiobeeper CB12/12, Model CB12/12

  Class II

  FDA 510(k) K002310 Active Cleared 25 Oct 2000

• Prime ECG System

  Class II

  FDA 510(k) K030104 Active Cleared 11 Jun 2003

• Cardiobeeper Cb-12l

  Class II

  FDA 510(k) K965101 Active Cleared 17 Mar 1997

• Cardiobeeper CB250

  Class II

  FDA 510(k) K983582 Active Cleared 13 Nov 1998

• Prime ECG System

  Class II

  FDA 510(k) K012414 Active Cleared 6 Mar 2002

• What is the Bridge III Receiver used for?

  The Bridge III Receiver is a transmitter and receiver, electrocardiograph, telephone device designed for use in cardiovascular applications, enabling ECG signal transmission and reception over telephone lines.

• Who manufactures the Bridge III Receiver and where is it made?

  The Bridge III Receiver is manufactured by Meridian Medical Technologies, Ltd. in Belfast, Northern Ireland, as specified in the device’s FDA 510(k) submission records.

• What regulatory pathway was used for the Bridge III Receiver’s clearance?

  The Bridge III Receiver received FDA 510(k) clearance through a traditional submission process, identified as K010794, and was found substantially equivalent to a predicate device.

• What is the device classification and regulation number for the Bridge III Receiver?

  The Bridge III Receiver is classified as a Class II medical device under regulation number 870.2920, with product code DXH, as defined in the FDA’s device classification system.