FDA 510(k)

MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26

K-Number: K122404 · 2013-05-06

ApplicantRepro-Med Systems, Inc. Dba Rms Medical Products

Decision Date2013-05-06

Product CodeFPA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc. Dba Rms Medical Products. It received FDA 510(k) clearance on 2013-05-06 under 510(k) number K122404. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26?

MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 is a medical device that received FDA 510(k) clearance on 2013-05-06. The listed applicant is Repro-Med Systems, Inc. Dba Rms Medical Products. The 510(k) number is K122404.

When did MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 receive FDA 510(k) clearance?

MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 received FDA 510(k) clearance on 2013-05-06, under 510(k) number K122404.

Who is the listed applicant for MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26?

The FDA 510(k) record lists Repro-Med Systems, Inc. Dba Rms Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26?

The FDA product code for MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 is FPA.

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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.