Doppler Ultrasonic Stethoscope

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

510(k) Number

K801512 ↗

FDA Product Code

IYN

Device Class

Class II

Regulation

21 CFR Part 892.1550

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Mountain Medical Equipment, Inc. →

• What is the Doppler Ultrasonic Stethoscope used for?

  The Doppler Ultrasonic Stethoscope is a Class II ultrasound system used in radiology for diagnostic purposes. It utilizes ultrasonic technology to provide imaging capabilities through the Doppler effect.

• Is the Doppler Ultrasonic Stethoscope single-use or reusable?

  The Doppler Ultrasonic Stethoscope is supplied as either a single-use or reusable product depending on the model selected. The specific model determines whether it can be reused or is intended for single use only.

• What regulatory approvals does the Doppler Ultrasonic Stethoscope have?

  The Doppler Ultrasonic Stethoscope received FDA 510(k) clearance with number K801512 on August 20, 1980. It is classified under product code IYN and is manufactured by Mountain Medical Equipment, Inc.

• What are the specifications of the Doppler Ultrasonic Stethoscope?

  The device is a Class II ultrasound system with imaging capabilities through the Doppler effect. It was determined to be substantially equivalent through the traditional clearance process and reviewed by the Radiology advisory committee.