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FDA 510(k)

PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R

K-Number: K071909 · 2007-10-18

ApplicantBarkey GmbH & Co. KG
Decision Date2007-10-18
Product CodeKOC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R is the device name listed in this FDA 510(k) record. The listed applicant is Barkey GmbH & Co. KG. It received FDA 510(k) clearance on 2007-10-18 under 510(k) number K071909. The device is classified under product code KOC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R?

PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R is a medical device that received FDA 510(k) clearance on 2007-10-18. The listed applicant is Barkey GmbH & Co. KG. The 510(k) number is K071909.

When did PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R receive FDA 510(k) clearance?

PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R received FDA 510(k) clearance on 2007-10-18, under 510(k) number K071909.

Who is the listed applicant for PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R?

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

What is the FDA product code for PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R?

The FDA product code for PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R is KOC.

Related Clinical Trials

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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Other records listing Barkey GmbH & Co. KG as applicant

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.

K213191S-Line

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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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