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FDA 510(k)

Biim Diagnostic Ultrasound System

K-Number: K173138 · 2017-10-27

ApplicantBiim Ultrasound AS
Decision Date2017-10-27
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Biim Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Biim Ultrasound AS. It received FDA 510(k) clearance on 2017-10-27 under 510(k) number K173138. 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 Biim Diagnostic Ultrasound System?

Biim Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-10-27. The listed applicant is Biim Ultrasound AS. The 510(k) number is K173138.

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

Biim Diagnostic Ultrasound System received FDA 510(k) clearance on 2017-10-27, under 510(k) number K173138.

Who is the listed applicant for Biim Diagnostic Ultrasound System?

The FDA 510(k) record lists Biim Ultrasound AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biim Diagnostic Ultrasound System?

The FDA product code for Biim 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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