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FDA 510(k)

MOLDED CRANIAL HELMET

K-Number: K012920 · 2001-11-28

ApplicantFairview Orthopedic Laboratory
Decision Date2001-11-28
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MOLDED CRANIAL HELMET is the device name listed in this FDA 510(k) record. The listed applicant is Fairview Orthopedic Laboratory. It received FDA 510(k) clearance on 2001-11-28 under 510(k) number K012920. 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 MOLDED CRANIAL HELMET?

MOLDED CRANIAL HELMET is a medical device that received FDA 510(k) clearance on 2001-11-28. The listed applicant is Fairview Orthopedic Laboratory. The 510(k) number is K012920.

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

MOLDED CRANIAL HELMET received FDA 510(k) clearance on 2001-11-28, under 510(k) number K012920.

Who is the listed applicant for MOLDED CRANIAL HELMET?

The FDA 510(k) record lists Fairview Orthopedic Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOLDED CRANIAL HELMET?

The FDA product code for MOLDED CRANIAL HELMET is MVA.

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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.

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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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