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FDA 510(k)

DYNATRON 438

K-Number: K870515 · 1987-06-16

ApplicantHenley Intl.
Decision Date1987-06-16
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DYNATRON 438 is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1987-06-16 under 510(k) number K870515. 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 DYNATRON 438?

DYNATRON 438 is a medical device that received FDA 510(k) clearance on 1987-06-16. The listed applicant is Henley Intl.. The 510(k) number is K870515.

When did DYNATRON 438 receive FDA 510(k) clearance?

DYNATRON 438 received FDA 510(k) clearance on 1987-06-16, under 510(k) number K870515.

Who is the listed applicant for DYNATRON 438?

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

What is the FDA product code for DYNATRON 438?

The FDA product code for DYNATRON 438 is IPF.

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Other records listing Henley Intl. 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

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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