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FDA 510(k)

RMX PHYSIOLOGICAL DATA RECORDER

K-Number: K080375 · 2008-09-02

ApplicantS.L.P. , Ltd.
Decision Date2008-09-02
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RMX PHYSIOLOGICAL DATA RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is S.L.P. , Ltd.. It received FDA 510(k) clearance on 2008-09-02 under 510(k) number K080375. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMX PHYSIOLOGICAL DATA RECORDER?

RMX PHYSIOLOGICAL DATA RECORDER is a medical device that received FDA 510(k) clearance on 2008-09-02. The listed applicant is S.L.P. , Ltd.. The 510(k) number is K080375.

When did RMX PHYSIOLOGICAL DATA RECORDER receive FDA 510(k) clearance?

RMX PHYSIOLOGICAL DATA RECORDER received FDA 510(k) clearance on 2008-09-02, under 510(k) number K080375.

Who is the listed applicant for RMX PHYSIOLOGICAL DATA RECORDER?

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

What is the FDA product code for RMX PHYSIOLOGICAL DATA RECORDER?

The FDA product code for RMX PHYSIOLOGICAL DATA RECORDER is MNR.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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