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FDA 510(k)

SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT

K-Number: K872394 · 1987-09-03

ApplicantHenley Intl.
Decision Date1987-09-03
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT is the device name listed in this FDA 510(k) record. The listed applicant is Henley Intl.. It received FDA 510(k) clearance on 1987-09-03 under 510(k) number K872394. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT?

SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT is a medical device that received FDA 510(k) clearance on 1987-09-03. The listed applicant is Henley Intl.. The 510(k) number is K872394.

When did SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT receive FDA 510(k) clearance?

SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT received FDA 510(k) clearance on 1987-09-03, under 510(k) number K872394.

Who is the listed applicant for SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT?

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 SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT?

The FDA product code for SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT is IMG.

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Related Devices (Code: IMG)

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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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