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FDA 510(k)

STATIC VESSEL ANALYZER

K-Number: K082196 · 2009-06-16

ApplicantImedos GmbH
Decision Date2009-06-16
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

STATIC VESSEL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Imedos GmbH. It received FDA 510(k) clearance on 2009-06-16 under 510(k) number K082196. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATIC VESSEL ANALYZER?

STATIC VESSEL ANALYZER is a medical device that received FDA 510(k) clearance on 2009-06-16. The listed applicant is Imedos GmbH. The 510(k) number is K082196.

When did STATIC VESSEL ANALYZER receive FDA 510(k) clearance?

STATIC VESSEL ANALYZER received FDA 510(k) clearance on 2009-06-16, under 510(k) number K082196.

Who is the listed applicant for STATIC VESSEL ANALYZER?

The FDA 510(k) record lists Imedos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STATIC VESSEL ANALYZER?

The FDA product code for STATIC VESSEL ANALYZER is HKI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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