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FDA 510(k)

EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM

K-Number: K131595 · 2013-07-26

ApplicantEurotrol B.V.
Decision Date2013-07-26
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM is the device name listed in this FDA 510(k) record. The listed applicant is Eurotrol B.V.. It received FDA 510(k) clearance on 2013-07-26 under 510(k) number K131595. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM?

EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM is a medical device that received FDA 510(k) clearance on 2013-07-26. The listed applicant is Eurotrol B.V.. The 510(k) number is K131595.

When did EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM receive FDA 510(k) clearance?

EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM received FDA 510(k) clearance on 2013-07-26, under 510(k) number K131595.

Who is the listed applicant for EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM?

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

What is the FDA product code for EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM?

The FDA product code for EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM is JJY.

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Other records listing Eurotrol B.V. as applicant

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Related Devices (Code: JJY)

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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