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FDA 510(k)

ICE COMPRESSION FIRST, DUO, & MOOVE Systems

K-Number: K193079 · 2021-01-11

ApplicantMks Paris
Decision Date2021-01-11
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ICE COMPRESSION FIRST, DUO, & MOOVE Systems is the device name listed in this FDA 510(k) record. The listed applicant is Mks Paris. It received FDA 510(k) clearance on 2021-01-11 under 510(k) number K193079. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICE COMPRESSION FIRST, DUO, & MOOVE Systems?

ICE COMPRESSION FIRST, DUO, & MOOVE Systems is a medical device that received FDA 510(k) clearance on 2021-01-11. The listed applicant is Mks Paris. The 510(k) number is K193079.

When did ICE COMPRESSION FIRST, DUO, & MOOVE Systems receive FDA 510(k) clearance?

ICE COMPRESSION FIRST, DUO, & MOOVE Systems received FDA 510(k) clearance on 2021-01-11, under 510(k) number K193079.

Who is the listed applicant for ICE COMPRESSION FIRST, DUO, & MOOVE Systems?

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

What is the FDA product code for ICE COMPRESSION FIRST, DUO, & MOOVE Systems?

The FDA product code for ICE COMPRESSION FIRST, DUO, & MOOVE Systems is IRP.

Related Devices (Code: IRP)

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.

Official Source

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