Interval Timer Model V4295

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

510(k) Number

K790203 ↗

FDA Product Code

DRR

Device Class

Class II

Regulation

21 CFR Part 870.2050

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary function of the Interval Timer Model V4295?

  The Model V4295 serves as a biopotential amplifier and signal conditioner. It is specifically designed to process physiological signals within cardiovascular clinical applications.

• How is this device classified for regulatory purposes?

  The Interval Timer Model V4295 is classified as a Class 2 medical device under regulation number 870.2050. It received FDA 510K authorization under K790203, confirming it as substantially equivalent to existing devices.

• Which medical specialty is this device intended for?

  This device is intended for use within the cardiovascular medical specialty. It is categorized under the cardiovascular advisory committee to ensure it meets the necessary standards for processing physiological signals in that field.