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FDA 510(k)

MERIDIAN CRANIAL PERFORATOR

K-Number: K121253 · 2012-07-17

ApplicantAdeor Medical Technologies GmbH
Decision Date2012-07-17
Product CodeHBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MERIDIAN CRANIAL PERFORATOR is the device name listed in this FDA 510(k) record. The listed applicant is Adeor Medical Technologies GmbH. It received FDA 510(k) clearance on 2012-07-17 under 510(k) number K121253. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERIDIAN CRANIAL PERFORATOR?

MERIDIAN CRANIAL PERFORATOR is a medical device that received FDA 510(k) clearance on 2012-07-17. The listed applicant is Adeor Medical Technologies GmbH. The 510(k) number is K121253.

When did MERIDIAN CRANIAL PERFORATOR receive FDA 510(k) clearance?

MERIDIAN CRANIAL PERFORATOR received FDA 510(k) clearance on 2012-07-17, under 510(k) number K121253.

Who is the listed applicant for MERIDIAN CRANIAL PERFORATOR?

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

What is the FDA product code for MERIDIAN CRANIAL PERFORATOR?

The FDA product code for MERIDIAN CRANIAL PERFORATOR is HBF.

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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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