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FDA 510(k)

RAOMER

K-Number: K894112 · 1989-07-25

ApplicantNiagara Corp.
Decision Date1989-07-25
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

RAOMER is the device name listed in this FDA 510(k) record. The listed applicant is Niagara Corp.. It received FDA 510(k) clearance on 1989-07-25 under 510(k) number K894112. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAOMER?

RAOMER is a medical device that received FDA 510(k) clearance on 1989-07-25. The listed applicant is Niagara Corp.. The 510(k) number is K894112.

When did RAOMER receive FDA 510(k) clearance?

RAOMER received FDA 510(k) clearance on 1989-07-25, under 510(k) number K894112.

Who is the listed applicant for RAOMER?

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

What is the FDA product code for RAOMER?

The FDA product code for RAOMER is INI.

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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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