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FDA 510(k)

ULTRASOUND STETHOSCOPE(R) INTRADOP(R)

K-Number: K912033 · 1991-10-15

ApplicantMedadonics, Inc.
Decision Date1991-10-15
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASOUND STETHOSCOPE(R) INTRADOP(R) is the device name listed in this FDA 510(k) record. The listed applicant is Medadonics, Inc.. It received FDA 510(k) clearance on 1991-10-15 under 510(k) number K912033. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND STETHOSCOPE(R) INTRADOP(R)?

ULTRASOUND STETHOSCOPE(R) INTRADOP(R) is a medical device that received FDA 510(k) clearance on 1991-10-15. The listed applicant is Medadonics, Inc.. The 510(k) number is K912033.

When did ULTRASOUND STETHOSCOPE(R) INTRADOP(R) receive FDA 510(k) clearance?

ULTRASOUND STETHOSCOPE(R) INTRADOP(R) received FDA 510(k) clearance on 1991-10-15, under 510(k) number K912033.

Who is the listed applicant for ULTRASOUND STETHOSCOPE(R) INTRADOP(R)?

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

What is the FDA product code for ULTRASOUND STETHOSCOPE(R) INTRADOP(R)?

The FDA product code for ULTRASOUND STETHOSCOPE(R) INTRADOP(R) is JAF.

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Related Devices (Code: JAF)

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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.

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