DOC Band 3D— 510(k) K244056

Substantially Equivalent

Cranial Technologies, Inc.

FDA 510(k) clearance K244056 for DOC Band 3D, Substantially Equivalent on 2025-03-17. Applicant: Cranial Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Cranial Technologies, Inc.
Product code: Code OAN
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2024-12-31
Decision date: 2025-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Cranial Technologies, Inc.

K042385 — DOC BAND-POSTOP2004-12-17
K014012 — DOC BAND2002-01-28
DEN980001 — DYNAMIC ORTHOTIC CRANIOPLASTY BAND; DOC BAND1998-05-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.