FDA 510(k)

mediCAD 4.0

K-Number: K170702 · 2018-09-07

Decision Date2018-09-07

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

mediCAD 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medicad Hectec GmbH. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K170702. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the mediCAD 4.0?

mediCAD 4.0 is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Medicad Hectec GmbH. The 510(k) number is K170702.

When did mediCAD 4.0 receive FDA 510(k) clearance?

mediCAD 4.0 received FDA 510(k) clearance on 2018-09-07, under 510(k) number K170702.

Who is the listed applicant for mediCAD 4.0?

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

What is the FDA product code for mediCAD 4.0?

The FDA product code for mediCAD 4.0 is LLZ.

Other records listing Medicad Hectec GmbH 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.

K183412mediCAD Web

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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.