FDA 510(k)

Hang&Go PAC

K-Number: K161613 · 2016-12-28

Decision Date2016-12-28

Product CodeLGZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Hang&Go PAC is the device name listed in this FDA 510(k) record. The listed applicant is Rand S.R.L.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K161613. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hang&Go PAC?

Hang&Go PAC is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Rand S.R.L.. The 510(k) number is K161613.

When did Hang&Go PAC receive FDA 510(k) clearance?

Hang&Go PAC received FDA 510(k) clearance on 2016-12-28, under 510(k) number K161613.

Who is the listed applicant for Hang&Go PAC?

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

What is the FDA product code for Hang&Go PAC?

The FDA product code for Hang&Go PAC is LGZ.

Related Devices (Code: LGZ)

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.

K260988°M Warmer System with °M StationMequ A/S K252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/S K211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd.

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.