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FDA 510(k)

ACUSON P500 Ultrasound System

K-Number: K163396 · 2017-01-04

Decision Date2017-01-04
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON P500 Ultrasound System is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-01-04 under approval number K163396. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUSON P500 Ultrasound System?

ACUSON P500 Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-01-04. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K163396.

When was ACUSON P500 Ultrasound System approved by the FDA?

ACUSON P500 Ultrasound System received FDA 510(k) clearance on 2017-01-04, under approval number K163396.

What company makes ACUSON P500 Ultrasound System?

ACUSON P500 Ultrasound System is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for ACUSON P500 Ultrasound System?

The FDA product code for ACUSON P500 Ultrasound System is IYN.

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Official Source

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