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FDA 510(k)

POLARIS 100/200

K-Number: K123776 · 2013-03-08

ApplicantDrager Medical GmbH
Decision Date2013-03-08
Product CodeFTD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POLARIS 100/200 is the device name listed in this FDA 510(k) record. The listed applicant is Drager Medical GmbH. It received FDA 510(k) clearance on 2013-03-08 under 510(k) number K123776. The device is classified under product code FTD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLARIS 100/200?

POLARIS 100/200 is a medical device that received FDA 510(k) clearance on 2013-03-08. The listed applicant is Drager Medical GmbH. The 510(k) number is K123776.

When did POLARIS 100/200 receive FDA 510(k) clearance?

POLARIS 100/200 received FDA 510(k) clearance on 2013-03-08, under 510(k) number K123776.

Who is the listed applicant for POLARIS 100/200?

The FDA 510(k) record lists Drager Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLARIS 100/200?

The FDA product code for POLARIS 100/200 is FTD.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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