FDA 510(k)

DOLPHIN 3 FLUID MANAGEMENT SYSTEM

K-Number: K110852 · 2011-07-19

Decision Date2011-07-19

Product CodeHIG

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

DOLPHIN 3 FLUID MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2011-07-19 under 510(k) number K110852. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOLPHIN 3 FLUID MANAGEMENT SYSTEM?

DOLPHIN 3 FLUID MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-19. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K110852.

When did DOLPHIN 3 FLUID MANAGEMENT SYSTEM receive FDA 510(k) clearance?

DOLPHIN 3 FLUID MANAGEMENT SYSTEM received FDA 510(k) clearance on 2011-07-19, under 510(k) number K110852.

Who is the listed applicant for DOLPHIN 3 FLUID MANAGEMENT SYSTEM?

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

What is the FDA product code for DOLPHIN 3 FLUID MANAGEMENT SYSTEM?

The FDA product code for DOLPHIN 3 FLUID MANAGEMENT SYSTEM is HIG.

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Related Devices (Code: HIG)

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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.