Model M1175A/M1176A With ST Segment Monitoring

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

510(k) Number

K900032 ↗

FDA Product Code

DRT

Device Class

Class II

Regulation

21 CFR Part 870.2300

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary function of the Model M1175A/M1176A With ST Segment Monitoring?

  The device is a cardiac monitor designed to monitor cardiac function. It includes a cardiotachometer and a rate alarm to assist in tracking heart activity.

• How is the device supplied and is it reusable?

  The device is supplied as a single-use item intended for use in a clinical setting. It is not specified as reusable.

• What regulatory pathway does this device follow?

  The device is regulated under the US FDA 510(k) program and has a product code of DRT.