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FDA 510(k)

WILLCARE, MODEL GW-1020

K-Number: K052594 · 2006-02-10

ApplicantIcu Medical, Inc.
Decision Date2006-02-10
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WILLCARE, MODEL GW-1020 is the device name listed in this FDA 510(k) record. The listed applicant is Icu Medical, Inc.. It received FDA 510(k) clearance on 2006-02-10 under 510(k) number K052594. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILLCARE, MODEL GW-1020?

WILLCARE, MODEL GW-1020 is a medical device that received FDA 510(k) clearance on 2006-02-10. The listed applicant is Icu Medical, Inc.. The 510(k) number is K052594.

When did WILLCARE, MODEL GW-1020 receive FDA 510(k) clearance?

WILLCARE, MODEL GW-1020 received FDA 510(k) clearance on 2006-02-10, under 510(k) number K052594.

Who is the listed applicant for WILLCARE, MODEL GW-1020?

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

What is the FDA product code for WILLCARE, MODEL GW-1020?

The FDA product code for WILLCARE, MODEL GW-1020 is FRN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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