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FDA 510(k)

Hospira Extension Sets

K-Number: K151969 · 2016-01-19

ApplicantIcu Medical, Inc.
Decision Date2016-01-19
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hospira Extension Sets 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 2016-01-19 under 510(k) number K151969. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hospira Extension Sets?

Hospira Extension Sets is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Icu Medical, Inc.. The 510(k) number is K151969.

When did Hospira Extension Sets receive FDA 510(k) clearance?

Hospira Extension Sets received FDA 510(k) clearance on 2016-01-19, under 510(k) number K151969.

Who is the listed applicant for Hospira Extension Sets?

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 Hospira Extension Sets?

The FDA product code for Hospira Extension Sets is FPA.

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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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