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FDA 510(k)

POSI-LINK

K-Number: K000472 · 2000-05-10

ApplicantIcu Medical, Inc.
Decision Date2000-05-10
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POSI-LINK 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 2000-05-10 under 510(k) number K000472. 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 POSI-LINK?

POSI-LINK is a medical device that received FDA 510(k) clearance on 2000-05-10. The listed applicant is Icu Medical, Inc.. The 510(k) number is K000472.

When did POSI-LINK receive FDA 510(k) clearance?

POSI-LINK received FDA 510(k) clearance on 2000-05-10, under 510(k) number K000472.

Who is the listed applicant for POSI-LINK?

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 POSI-LINK?

The FDA product code for POSI-LINK is FPA.

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Related Devices (Code: 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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