FDA 510(k)

PLANET 55, MODEL 100

K-Number: K090443 · 2009-06-05

Decision Date2009-06-05

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PLANET 55, MODEL 100 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 2009-06-05 under 510(k) number K090443. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLANET 55, MODEL 100?

PLANET 55, MODEL 100 is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is Larsen & Toubro Limited. The 510(k) number is K090443.

When did PLANET 55, MODEL 100 receive FDA 510(k) clearance?

PLANET 55, MODEL 100 received FDA 510(k) clearance on 2009-06-05, under 510(k) number K090443.

Who is the listed applicant for PLANET 55, MODEL 100?

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 PLANET 55, MODEL 100?

The FDA product code for PLANET 55, MODEL 100 is MHX.

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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.