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FDA 510(k)

MODIFICATION TO MODEL 90-1460 LASER ADAPTER

K-Number: K911523 · 1991-04-22

ApplicantLifestream Int'L, Inc.
Decision Date1991-04-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MODEL 90-1460 LASER ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Int'L, Inc.. It received FDA 510(k) clearance on 1991-04-22 under 510(k) number K911523. 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 MODIFICATION TO MODEL 90-1460 LASER ADAPTER?

MODIFICATION TO MODEL 90-1460 LASER ADAPTER is a medical device that received FDA 510(k) clearance on 1991-04-22. The listed applicant is Lifestream Int'L, Inc.. The 510(k) number is K911523.

When did MODIFICATION TO MODEL 90-1460 LASER ADAPTER receive FDA 510(k) clearance?

MODIFICATION TO MODEL 90-1460 LASER ADAPTER received FDA 510(k) clearance on 1991-04-22, under 510(k) number K911523.

Who is the listed applicant for MODIFICATION TO MODEL 90-1460 LASER ADAPTER?

The FDA 510(k) record lists Lifestream Int'L, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO MODEL 90-1460 LASER ADAPTER?

The FDA product code for MODIFICATION TO MODEL 90-1460 LASER ADAPTER is GEX. This falls under the Gastroenterology category.

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Other records listing Lifestream Int'L, 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.

K964571VISION CARDIOPLEGIA DELIVERY SYSTEMK962354DIOMED 15, 30, 60 SURGICAL DIODE LASERK920178CARDIOTOMY RESERVOIR W/20 MICRON FILITERK920618AUTOTRANSFUSION SUCTION SETK913181AUTOLOGOUS BLOOD PROCESSING SYSTEMK914396SURGI LIGHT NON-CONTACT FIBERS

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Related Devices (Code: GEX)

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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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