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FDA 510(k)

DOC Band 3D

K-Number: K244056 · 2025-03-17

ApplicantCranial Technologies, Inc.
Decision Date2025-03-17
Product CodeOAN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DOC Band 3D is a medical device manufactured by Cranial Technologies, Inc.. It received FDA 510(k) clearance on 2025-03-17 under approval number K244056. The device is classified under product code OAN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOC Band 3D?

DOC Band 3D is a medical device that received FDA 510(k) clearance on 2025-03-17. It is manufactured by Cranial Technologies, Inc.. The 510(k) number is K244056.

When was DOC Band 3D approved by the FDA?

DOC Band 3D received FDA 510(k) clearance on 2025-03-17, under approval number K244056.

What company makes DOC Band 3D?

DOC Band 3D is manufactured by Cranial Technologies, Inc..

What is the FDA product code for DOC Band 3D?

The FDA product code for DOC Band 3D is OAN.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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