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FDA 510(k)

POLESTAR N-10

K-Number: K002242 · 2000-09-20

ApplicantOdin Technologies , Ltd.
Decision Date2000-09-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POLESTAR N-10 is the device name listed in this FDA 510(k) record. The listed applicant is Odin Technologies , Ltd.. It received FDA 510(k) clearance on 2000-09-20 under 510(k) number K002242. 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-10?

POLESTAR N-10 is a medical device that received FDA 510(k) clearance on 2000-09-20. The listed applicant is Odin Technologies , Ltd.. The 510(k) number is K002242.

When did POLESTAR N-10 receive FDA 510(k) clearance?

POLESTAR N-10 received FDA 510(k) clearance on 2000-09-20, under 510(k) number K002242.

Who is the listed applicant for POLESTAR N-10?

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

What is the FDA product code for POLESTAR N-10?

The FDA product code for POLESTAR N-10 is LNH.

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Other records listing Odin Technologies , Ltd. 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.

K991243NORMA 10

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Official Source

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