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FDA 510(k)

LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET

K-Number: K023572 · 2003-01-13

ApplicantRehabilitation Institute,Loma Linda University Med
Decision Date2003-01-13
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET is the device name listed in this FDA 510(k) record. The listed applicant is Rehabilitation Institute,Loma Linda University Med. It received FDA 510(k) clearance on 2003-01-13 under 510(k) number K023572. 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 LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET?

LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET is a medical device that received FDA 510(k) clearance on 2003-01-13. The listed applicant is Rehabilitation Institute,Loma Linda University Med. The 510(k) number is K023572.

When did LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET receive FDA 510(k) clearance?

LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET received FDA 510(k) clearance on 2003-01-13, under 510(k) number K023572.

Who is the listed applicant for LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET?

The FDA 510(k) record lists Rehabilitation Institute,Loma Linda University Med as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET?

The FDA product code for LOMA LINDA UNIVERSITY MEDICAL CENTER (LLUMC) CRANIAL REMOLDING HELMET is MVA.

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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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