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FDA 510(k)

AM-YAG

K-Number: K950825 · 1995-08-28

ApplicantAmerican Lasers, Inc.
Decision Date1995-08-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AM-YAG is the device name listed in this FDA 510(k) record. The listed applicant is American Lasers, Inc.. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K950825. 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 AM-YAG?

AM-YAG is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is American Lasers, Inc.. The 510(k) number is K950825.

When did AM-YAG receive FDA 510(k) clearance?

AM-YAG received FDA 510(k) clearance on 1995-08-28, under 510(k) number K950825.

Who is the listed applicant for AM-YAG?

The FDA 510(k) record lists American Lasers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AM-YAG?

The FDA product code for AM-YAG is GEX. This falls under the Gastroenterology category.

Other records listing American Lasers, Inc. 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.

K061850MINI-YAG LASERK974142HM-RUBYK970475MM-RUBYK950826AM RUBY

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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