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FDA 510(k)

SKYLINE 55, MODEL VER 1

K-Number: K092153 · 2009-11-20

ApplicantLarsen & Toubro Limited
Decision Date2009-11-20
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKYLINE 55, MODEL VER 1 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 2009-11-20 under 510(k) number K092153. 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 SKYLINE 55, MODEL VER 1?

SKYLINE 55, MODEL VER 1 is a medical device that received FDA 510(k) clearance on 2009-11-20. The listed applicant is Larsen & Toubro Limited. The 510(k) number is K092153.

When did SKYLINE 55, MODEL VER 1 receive FDA 510(k) clearance?

SKYLINE 55, MODEL VER 1 received FDA 510(k) clearance on 2009-11-20, under 510(k) number K092153.

Who is the listed applicant for SKYLINE 55, MODEL VER 1?

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 SKYLINE 55, MODEL VER 1?

The FDA product code for SKYLINE 55, MODEL VER 1 is MWI.

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Other records listing Larsen & Toubro Limited as applicant

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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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