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FDA 510(k)

SPINNING SPIROS, MODEL CH-2000

K-Number: K082806 · 2009-04-06

ApplicantIcu Medical, Inc.
Decision Date2009-04-06
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPINNING SPIROS, MODEL CH-2000 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 2009-04-06 under 510(k) number K082806. 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 SPINNING SPIROS, MODEL CH-2000?

SPINNING SPIROS, MODEL CH-2000 is a medical device that received FDA 510(k) clearance on 2009-04-06. The listed applicant is Icu Medical, Inc.. The 510(k) number is K082806.

When did SPINNING SPIROS, MODEL CH-2000 receive FDA 510(k) clearance?

SPINNING SPIROS, MODEL CH-2000 received FDA 510(k) clearance on 2009-04-06, under 510(k) number K082806.

Who is the listed applicant for SPINNING SPIROS, MODEL CH-2000?

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 SPINNING SPIROS, MODEL CH-2000?

The FDA product code for SPINNING SPIROS, MODEL CH-2000 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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