FDA 510(k)

DOPPLER ULTRASONIC STETHOSCOPE

K-Number: K801512 · 1980-08-20

ApplicantMountain Medical Equipment, Inc.

Decision Date1980-08-20

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DOPPLER ULTRASONIC STETHOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Mountain Medical Equipment, Inc.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801512. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOPPLER ULTRASONIC STETHOSCOPE?

DOPPLER ULTRASONIC STETHOSCOPE is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Mountain Medical Equipment, Inc.. The 510(k) number is K801512.

When did DOPPLER ULTRASONIC STETHOSCOPE receive FDA 510(k) clearance?

DOPPLER ULTRASONIC STETHOSCOPE received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801512.

Who is the listed applicant for DOPPLER ULTRASONIC STETHOSCOPE?

The FDA 510(k) record lists Mountain Medical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOPPLER ULTRASONIC STETHOSCOPE?

The FDA product code for DOPPLER ULTRASONIC STETHOSCOPE is IYN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.