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FDA 510(k)

MYO-TRAIN V (5)

K-Number: K980158 · 1998-07-28

ApplicantSterne Equipment Co., Ltd.
Decision Date1998-07-28
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MYO-TRAIN V (5) 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 1998-07-28 under 510(k) number K980158. 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 MYO-TRAIN V (5)?

MYO-TRAIN V (5) is a medical device that received FDA 510(k) clearance on 1998-07-28. The listed applicant is Sterne Equipment Co., Ltd.. The 510(k) number is K980158.

When did MYO-TRAIN V (5) receive FDA 510(k) clearance?

MYO-TRAIN V (5) received FDA 510(k) clearance on 1998-07-28, under 510(k) number K980158.

Who is the listed applicant for MYO-TRAIN V (5)?

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 MYO-TRAIN V (5)?

The FDA product code for MYO-TRAIN V (5) 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.

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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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