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FDA 510(k)

Acclarix AX8 Diagnostic Ultrasound System

K-Number: K161300 · 2016-05-31

ApplicantEdan Instruments, Inc.
Decision Date2016-05-31
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Acclarix AX8 Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-05-31 under 510(k) number K161300. 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 Acclarix AX8 Diagnostic Ultrasound System?

Acclarix AX8 Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-05-31. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K161300.

When did Acclarix AX8 Diagnostic Ultrasound System receive FDA 510(k) clearance?

Acclarix AX8 Diagnostic Ultrasound System received FDA 510(k) clearance on 2016-05-31, under 510(k) number K161300.

Who is the listed applicant for Acclarix AX8 Diagnostic Ultrasound System?

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

What is the FDA product code for Acclarix AX8 Diagnostic Ultrasound System?

The FDA product code for Acclarix AX8 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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