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FDA 510(k)

MEDILASER MIC MODEL MEL-445C, 15W

K-Number: K852122 · 1985-08-20

ApplicantMochida Pharmaceutical Co., Ltd.
Decision Date1985-08-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDILASER MIC MODEL MEL-445C, 15W is the device name listed in this FDA 510(k) record. The listed applicant is Mochida Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 1985-08-20 under 510(k) number K852122. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDILASER MIC MODEL MEL-445C, 15W?

MEDILASER MIC MODEL MEL-445C, 15W is a medical device that received FDA 510(k) clearance on 1985-08-20. The listed applicant is Mochida Pharmaceutical Co., Ltd.. The 510(k) number is K852122.

When did MEDILASER MIC MODEL MEL-445C, 15W receive FDA 510(k) clearance?

MEDILASER MIC MODEL MEL-445C, 15W received FDA 510(k) clearance on 1985-08-20, under 510(k) number K852122.

Who is the listed applicant for MEDILASER MIC MODEL MEL-445C, 15W?

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

What is the FDA product code for MEDILASER MIC MODEL MEL-445C, 15W?

The FDA product code for MEDILASER MIC MODEL MEL-445C, 15W is GEX. This falls under the Gastroenterology category.

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Other records listing Mochida Pharmaceutical 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.

K233322Mochida Nerve CuffK852121MEDILASER MIC MODEL MEL 440-C;30WK840739MEDILASER-S MEL-444-S

Related Devices (Code: GEX)

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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