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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 the device name listed in this FDA 510(k) record. The listed applicant is Cranial Technologies, Inc.. It received FDA 510(k) clearance on 2025-03-17 under 510(k) 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. The listed applicant is Cranial Technologies, Inc.. The 510(k) number is K244056.

When did DOC Band 3D receive FDA 510(k) clearance?

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

Who is the listed applicant for DOC Band 3D?

The FDA 510(k) record lists Cranial Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: OAN)

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.

K240466STARband 3DOrthomerica Products, Inc.K211376STARbandOrthomerica Products, Inc.K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K161138St. Louis BandOrthomerica Products, Inc.

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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