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FDA 510(k)

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)

K-Number: K123902 · 2013-09-13

ApplicantOktx, LLC
Decision Date2013-09-13
Product CodeIKN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) is the device name listed in this FDA 510(k) record. The listed applicant is Oktx, LLC. It received FDA 510(k) clearance on 2013-09-13 under 510(k) number K123902. The device is classified under product code IKN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)?

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) is a medical device that received FDA 510(k) clearance on 2013-09-13. The listed applicant is Oktx, LLC. The 510(k) number is K123902.

When did PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) receive FDA 510(k) clearance?

PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) received FDA 510(k) clearance on 2013-09-13, under 510(k) number K123902.

Who is the listed applicant for PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)?

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

What is the FDA product code for PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)?

The FDA product code for PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S) is IKN.

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Related Devices (Code: IKN)

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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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