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FDA 510(k)

GALILEO HALLEY

K-Number: K970703 · 1997-05-19

ApplicantBiosound Esaote, Inc.
Decision Date1997-05-19
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GALILEO HALLEY 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 1997-05-19 under 510(k) number K970703. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALILEO HALLEY?

GALILEO HALLEY is a medical device that received FDA 510(k) clearance on 1997-05-19. The listed applicant is Biosound Esaote, Inc.. The 510(k) number is K970703.

When did GALILEO HALLEY receive FDA 510(k) clearance?

GALILEO HALLEY received FDA 510(k) clearance on 1997-05-19, under 510(k) number K970703.

Who is the listed applicant for GALILEO HALLEY?

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 GALILEO HALLEY?

The FDA product code for GALILEO HALLEY is GWQ.

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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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