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FDA 510(k)

CRANIAL HELMET

K-Number: K041215 · 2004-09-09

ApplicantOtto Bock Healthcare LP
Decision Date2004-09-09
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIAL HELMET is the device name listed in this FDA 510(k) record. The listed applicant is Otto Bock Healthcare LP. It received FDA 510(k) clearance on 2004-09-09 under 510(k) number K041215. 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 CRANIAL HELMET?

CRANIAL HELMET is a medical device that received FDA 510(k) clearance on 2004-09-09. The listed applicant is Otto Bock Healthcare LP. The 510(k) number is K041215.

When did CRANIAL HELMET receive FDA 510(k) clearance?

CRANIAL HELMET received FDA 510(k) clearance on 2004-09-09, under 510(k) number K041215.

Who is the listed applicant for CRANIAL HELMET?

The FDA 510(k) record lists Otto Bock Healthcare LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANIAL HELMET?

The FDA product code for CRANIAL HELMET is MVA.

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Other records listing Otto Bock Healthcare LP as applicant

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Related Devices (Code: MVA)

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.

K241957Talee, Talee PostOpInvent Medical USA, LLCK230444Talee, Talee PostOpInvent Medical USA, LLCK223238STARband 3DOrthomerica Products, Inc.K220681Talee, Talee PostOPInvent Medical USA, LLCK203134Hanger Cranial Band 3DSymbion Logistics, LLCK213587MyCRO BandOtto Bock Healthcare LP

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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