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FDA 510(k)

POLESTAR N-20

K-Number: K032541 · 2003-09-12

ApplicantOdin Medical Technologies , Ltd.
Decision Date2003-09-12
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POLESTAR N-20 is the device name listed in this FDA 510(k) record. The listed applicant is Odin Medical Technologies , Ltd.. It received FDA 510(k) clearance on 2003-09-12 under 510(k) number K032541. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLESTAR N-20?

POLESTAR N-20 is a medical device that received FDA 510(k) clearance on 2003-09-12. The listed applicant is Odin Medical Technologies , Ltd.. The 510(k) number is K032541.

When did POLESTAR N-20 receive FDA 510(k) clearance?

POLESTAR N-20 received FDA 510(k) clearance on 2003-09-12, under 510(k) number K032541.

Who is the listed applicant for POLESTAR N-20?

The FDA 510(k) record lists Odin Medical Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLESTAR N-20?

The FDA product code for POLESTAR N-20 is LNH.

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Other records listing Odin Medical Technologies , Ltd. as applicant

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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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