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FDA 510(k)

NATRATONE

K-Number: K121902 · 2013-06-06

ApplicantOrelle Corporation, Ltd.
Decision Date2013-06-06
Product CodeHIR
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NATRATONE is the device name listed in this FDA 510(k) record. The listed applicant is Orelle Corporation, Ltd.. It received FDA 510(k) clearance on 2013-06-06 under 510(k) number K121902. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NATRATONE?

NATRATONE is a medical device that received FDA 510(k) clearance on 2013-06-06. The listed applicant is Orelle Corporation, Ltd.. The 510(k) number is K121902.

When did NATRATONE receive FDA 510(k) clearance?

NATRATONE received FDA 510(k) clearance on 2013-06-06, under 510(k) number K121902.

Who is the listed applicant for NATRATONE?

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

What is the FDA product code for NATRATONE?

The FDA product code for NATRATONE is HIR.

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Related Devices (Code: HIR)

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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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