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FDA 510(k)

SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING

K-Number: K991842 · 1999-06-11

ApplicantGe Vingmed Ultrasound
Decision Date1999-06-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING is the device name listed in this FDA 510(k) record. The listed applicant is Ge Vingmed Ultrasound. It received FDA 510(k) clearance on 1999-06-11 under 510(k) number K991842. 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 SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING?

SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING is a medical device that received FDA 510(k) clearance on 1999-06-11. The listed applicant is Ge Vingmed Ultrasound. The 510(k) number is K991842.

When did SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING receive FDA 510(k) clearance?

SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING received FDA 510(k) clearance on 1999-06-11, under 510(k) number K991842.

Who is the listed applicant for SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING?

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

What is the FDA product code for SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING?

The FDA product code for SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING 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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