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FDA 510(k)

NEURO-TRAIN II (2)

K-Number: K970155 · 1997-03-17

ApplicantSterne Equipment Co., Ltd.
Decision Date1997-03-17
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NEURO-TRAIN II (2) 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 1997-03-17 under 510(k) number K970155. 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 II (2)?

NEURO-TRAIN II (2) is a medical device that received FDA 510(k) clearance on 1997-03-17. The listed applicant is Sterne Equipment Co., Ltd.. The 510(k) number is K970155.

When did NEURO-TRAIN II (2) receive FDA 510(k) clearance?

NEURO-TRAIN II (2) received FDA 510(k) clearance on 1997-03-17, under 510(k) number K970155.

Who is the listed applicant for NEURO-TRAIN II (2)?

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 II (2)?

The FDA product code for NEURO-TRAIN II (2) is IPF.

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

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.

K003433NEURO-TRAIN III (3)K980158MYO-TRAIN V (5)K972204ACU-RAY HF SERIES PORTABLE X-RAY UNITK931279ACU-RAYK883896NEUROTRAIN

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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