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FDA 510(k)

SKYLINE 55

K-Number: K081552 · 2008-07-31

ApplicantLarsen & Toubro Limited
Decision Date2008-07-31
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKYLINE 55 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 2008-07-31 under 510(k) number K081552. 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?

SKYLINE 55 is a medical device that received FDA 510(k) clearance on 2008-07-31. The listed applicant is Larsen & Toubro Limited. The 510(k) number is K081552.

When did SKYLINE 55 receive FDA 510(k) clearance?

SKYLINE 55 received FDA 510(k) clearance on 2008-07-31, under 510(k) number K081552.

Who is the listed applicant for SKYLINE 55?

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?

The FDA product code for SKYLINE 55 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 1K090443PLANET 55, MODEL 100K090172STAR 55 MODEL 100

View all 18 devices →

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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