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FDA 510(k)

CML 1000

K-Number: K051437 · 2005-08-03

ApplicantIcu Medical, Inc.
Decision Date2005-08-03
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CML 1000 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 2005-08-03 under 510(k) number K051437. 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 CML 1000?

CML 1000 is a medical device that received FDA 510(k) clearance on 2005-08-03. The listed applicant is Icu Medical, Inc.. The 510(k) number is K051437.

When did CML 1000 receive FDA 510(k) clearance?

CML 1000 received FDA 510(k) clearance on 2005-08-03, under 510(k) number K051437.

Who is the listed applicant for CML 1000?

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 CML 1000?

The FDA product code for CML 1000 is FPA.

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Related Devices (Code: FPA)

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.

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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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