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FDA 510(k)

GALAXY

K-Number: K061816 · 2006-07-12

ApplicantLarsen & Toubro Limited
Decision Date2006-07-12
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GALAXY is the device name listed in this FDA 510(k) record. The listed applicant is Larsen & Toubro Limited. It received FDA 510(k) clearance on 2006-07-12 under 510(k) number K061816. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALAXY?

GALAXY is a medical device that received FDA 510(k) clearance on 2006-07-12. The listed applicant is Larsen & Toubro Limited. The 510(k) number is K061816.

When did GALAXY receive FDA 510(k) clearance?

GALAXY received FDA 510(k) clearance on 2006-07-12, under 510(k) number K061816.

Who is the listed applicant for GALAXY?

The FDA 510(k) record lists Larsen & Toubro Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALAXY?

The FDA product code for GALAXY is MWI.

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Other records listing Larsen & Toubro Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K103686STAR 50 NK103763STELLAR 300K093017STELLAR 300K092153SKYLINE 55, MODEL VER 1K090172STAR 55 MODEL 100K090443PLANET 55, MODEL 100

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Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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