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FDA 510(k)

KidCap

K-Number: K180568 · 2018-10-16

Decision Date2018-10-16
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

KidCap is a medical device manufactured by Eastern Cranial Affiliates, LLC. It received FDA 510(k) clearance on 2018-10-16 under approval number K180568. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KidCap?

KidCap is a medical device that received FDA 510(k) clearance on 2018-10-16. It is manufactured by Eastern Cranial Affiliates, LLC. The 510(k) number is K180568.

When was KidCap approved by the FDA?

KidCap received FDA 510(k) clearance on 2018-10-16, under approval number K180568.

What company makes KidCap?

KidCap is manufactured by Eastern Cranial Affiliates, LLC.

What is the FDA product code for KidCap?

The FDA product code for KidCap is MVA.

Related Devices (Code: MVA)

Official Source

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