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FDA 510(k)

SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K992761 · 1999-09-01

ApplicantMedison America, Inc.
Decision Date1999-09-01
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medison America, Inc.. It received FDA 510(k) clearance on 1999-09-01 under 510(k) number K992761. 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 SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM?

SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-01. The listed applicant is Medison America, Inc.. The 510(k) number is K992761.

When did SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 1999-09-01, under 510(k) number K992761.

Who is the listed applicant for SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM?

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

What is the FDA product code for SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for SONOACE 5500 DIAGNOSTIC ULTRASOUND SYSTEM is IYO.

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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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