FDA 510(k)

Resmon PRO FULL

K-Number: K152585 · 2016-06-24

Decision Date2016-06-24

Product CodePNV

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Resmon PRO FULL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Graphics Corp.. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K152585. The device is classified under product code PNV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Resmon PRO FULL?

Resmon PRO FULL is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Medical Graphics Corp.. The 510(k) number is K152585.

When did Resmon PRO FULL receive FDA 510(k) clearance?

Resmon PRO FULL received FDA 510(k) clearance on 2016-06-24, under 510(k) number K152585.

Who is the listed applicant for Resmon PRO FULL?

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

What is the FDA product code for Resmon PRO FULL?

The FDA product code for Resmon PRO FULL is PNV.

Other records listing Medical Graphics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.