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FDA 510(k)

BALLERT CRANIAL MOLDING HELMET

K-Number: K011433 · 2001-06-12

ApplicantGema, Inc.
Decision Date2001-06-12
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BALLERT CRANIAL MOLDING HELMET is the device name listed in this FDA 510(k) record. The listed applicant is Gema, Inc.. It received FDA 510(k) clearance on 2001-06-12 under 510(k) number K011433. 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 BALLERT CRANIAL MOLDING HELMET?

BALLERT CRANIAL MOLDING HELMET is a medical device that received FDA 510(k) clearance on 2001-06-12. The listed applicant is Gema, Inc.. The 510(k) number is K011433.

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

BALLERT CRANIAL MOLDING HELMET received FDA 510(k) clearance on 2001-06-12, under 510(k) number K011433.

Who is the listed applicant for BALLERT CRANIAL MOLDING HELMET?

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

What is the FDA product code for BALLERT CRANIAL MOLDING HELMET?

The FDA product code for BALLERT CRANIAL MOLDING 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

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

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