FDA 510(k)

SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM

K-Number: K994096 · 1999-12-20

Decision Date1999-12-20

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sonosite,Inc.. It received FDA 510(k) clearance on 1999-12-20 under 510(k) number K994096. 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 SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM?

SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 1999-12-20. The listed applicant is Sonosite,Inc.. The 510(k) number is K994096.

When did SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM receive FDA 510(k) clearance?

SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM received FDA 510(k) clearance on 1999-12-20, under 510(k) number K994096.

Who is the listed applicant for SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM?

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

What is the FDA product code for SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM?

The FDA product code for SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM is IYN.

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Other records listing Sonosite,Inc. as applicant

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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.