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FDA 510(k)

7200 ULTRASOUND IMAGING SYSTEM

K-Number: K981293 · 1998-06-30

ApplicantBiosound Esaote, Inc.
Decision Date1998-06-30
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

7200 ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosound Esaote, Inc.. It received FDA 510(k) clearance on 1998-06-30 under 510(k) number K981293. 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 7200 ULTRASOUND IMAGING SYSTEM?

7200 ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-30. The listed applicant is Biosound Esaote, Inc.. The 510(k) number is K981293.

When did 7200 ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

7200 ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 1998-06-30, under 510(k) number K981293.

Who is the listed applicant for 7200 ULTRASOUND IMAGING SYSTEM?

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

What is the FDA product code for 7200 ULTRASOUND IMAGING SYSTEM?

The FDA product code for 7200 ULTRASOUND IMAGING 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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