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FDA 510(k)

GENIE, MODEL CH-200

K-Number: K070633 · 2007-06-05

ApplicantIcu Medical, Inc.
Decision Date2007-06-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GENIE, MODEL CH-200 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 2007-06-05 under 510(k) number K070633. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENIE, MODEL CH-200?

GENIE, MODEL CH-200 is a medical device that received FDA 510(k) clearance on 2007-06-05. The listed applicant is Icu Medical, Inc.. The 510(k) number is K070633.

When did GENIE, MODEL CH-200 receive FDA 510(k) clearance?

GENIE, MODEL CH-200 received FDA 510(k) clearance on 2007-06-05, under 510(k) number K070633.

Who is the listed applicant for GENIE, MODEL CH-200?

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 GENIE, MODEL CH-200?

The FDA product code for GENIE, MODEL CH-200 is FMF.

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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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