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FDA 510(k)

ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002

K-Number: K060215 · 2006-03-24

ApplicantEurotrol B.V.
Decision Date2006-03-24
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 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 2006-03-24 under 510(k) number K060215. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002?

ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 is a medical device that received FDA 510(k) clearance on 2006-03-24. The listed applicant is Eurotrol B.V.. The 510(k) number is K060215.

When did ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 receive FDA 510(k) clearance?

ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 received FDA 510(k) clearance on 2006-03-24, under 510(k) number K060215.

Who is the listed applicant for ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002?

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 ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002?

The FDA product code for ALBU TROL, LOW, MODEL 108.001.002; ALBU TROL, HIGH 108.002.002 is JJX.

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Other records listing Eurotrol B.V. as applicant

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Related Devices (Code: JJX)

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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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