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FDA 510(k)

ERKA. PERFECT-ANEROID

K-Number: K103637 · 2011-06-08

ApplicantErka Kallmeyer Medizintechnik GmbH
Decision Date2011-06-08
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ERKA. PERFECT-ANEROID is the device name listed in this FDA 510(k) record. The listed applicant is Erka Kallmeyer Medizintechnik GmbH. It received FDA 510(k) clearance on 2011-06-08 under 510(k) number K103637. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERKA. PERFECT-ANEROID?

ERKA. PERFECT-ANEROID is a medical device that received FDA 510(k) clearance on 2011-06-08. The listed applicant is Erka Kallmeyer Medizintechnik GmbH. The 510(k) number is K103637.

When did ERKA. PERFECT-ANEROID receive FDA 510(k) clearance?

ERKA. PERFECT-ANEROID received FDA 510(k) clearance on 2011-06-08, under 510(k) number K103637.

Who is the listed applicant for ERKA. PERFECT-ANEROID?

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

What is the FDA product code for ERKA. PERFECT-ANEROID?

The FDA product code for ERKA. PERFECT-ANEROID is DXQ.

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Official Source

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