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FDA 510(k)

LERMAN & SON CRANIAL ORTHOSIS HELMET

K-Number: K012830 · 2001-11-20

ApplicantLerman & Son
Decision Date2001-11-20
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LERMAN & SON CRANIAL ORTHOSIS HELMET is the device name listed in this FDA 510(k) record. The listed applicant is Lerman & Son. It received FDA 510(k) clearance on 2001-11-20 under 510(k) number K012830. 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 LERMAN & SON CRANIAL ORTHOSIS HELMET?

LERMAN & SON CRANIAL ORTHOSIS HELMET is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is Lerman & Son. The 510(k) number is K012830.

When did LERMAN & SON CRANIAL ORTHOSIS HELMET receive FDA 510(k) clearance?

LERMAN & SON CRANIAL ORTHOSIS HELMET received FDA 510(k) clearance on 2001-11-20, under 510(k) number K012830.

Who is the listed applicant for LERMAN & SON CRANIAL ORTHOSIS HELMET?

The FDA 510(k) record lists Lerman & Son as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LERMAN & SON CRANIAL ORTHOSIS HELMET?

The FDA product code for LERMAN & SON CRANIAL ORTHOSIS 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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