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FDA 510(k)

NEURO-TRAIN III (3)

K-Number: K003433 · 2001-06-15

ApplicantSterne Equipment Co., Ltd.
Decision Date2001-06-15
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEURO-TRAIN III (3) is the device name listed in this FDA 510(k) record. The listed applicant is Sterne Equipment Co., Ltd.. It received FDA 510(k) clearance on 2001-06-15 under 510(k) number K003433. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEURO-TRAIN III (3)?

NEURO-TRAIN III (3) is a medical device that received FDA 510(k) clearance on 2001-06-15. The listed applicant is Sterne Equipment Co., Ltd.. The 510(k) number is K003433.

When did NEURO-TRAIN III (3) receive FDA 510(k) clearance?

NEURO-TRAIN III (3) received FDA 510(k) clearance on 2001-06-15, under 510(k) number K003433.

Who is the listed applicant for NEURO-TRAIN III (3)?

The FDA 510(k) record lists Sterne Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEURO-TRAIN III (3)?

The FDA product code for NEURO-TRAIN III (3) is IPF.

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Other records listing Sterne Equipment Co., Ltd. as applicant

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Related Devices (Code: IPF)

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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