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FDA 510(k)

NORMA 10

K-Number: K991243 · 1999-06-18

ApplicantOdin Technologies , Ltd.
Decision Date1999-06-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NORMA 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 1999-06-18 under 510(k) number K991243. 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 NORMA 10?

NORMA 10 is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Odin Technologies , Ltd.. The 510(k) number is K991243.

When did NORMA 10 receive FDA 510(k) clearance?

NORMA 10 received FDA 510(k) clearance on 1999-06-18, under 510(k) number K991243.

Who is the listed applicant for NORMA 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 NORMA 10?

The FDA product code for NORMA 10 is LNH.

Related Clinical Trials

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.

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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.

K002242POLESTAR N-10

Related Devices (Code: LNH)

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.

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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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