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FDA 510(k)

SOUND IMAGER I

K-Number: K833231 · 1984-02-04

ApplicantSound Imaging, Inc.
Decision Date1984-02-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOUND IMAGER I is the device name listed in this FDA 510(k) record. The listed applicant is Sound Imaging, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K833231. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOUND IMAGER I?

SOUND IMAGER I is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Sound Imaging, Inc.. The 510(k) number is K833231.

When did SOUND IMAGER I receive FDA 510(k) clearance?

SOUND IMAGER I received FDA 510(k) clearance on 1984-02-04, under 510(k) number K833231.

Who is the listed applicant for SOUND IMAGER I?

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

What is the FDA product code for SOUND IMAGER I?

The FDA product code for SOUND IMAGER I is IYO.

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Official Source

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

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