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FDA 510(k)

TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700

K-Number: K851405 · 1985-10-07

ApplicantTrimedyne, Inc.
Decision Date1985-10-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1985-10-07 under 510(k) number K851405. 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 TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700?

TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 is a medical device that received FDA 510(k) clearance on 1985-10-07. The listed applicant is Trimedyne, Inc.. The 510(k) number is K851405.

When did TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 receive FDA 510(k) clearance?

TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 received FDA 510(k) clearance on 1985-10-07, under 510(k) number K851405.

Who is the listed applicant for TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700?

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

What is the FDA product code for TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700?

The FDA product code for TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 700 is GEX. This falls under the Gastroenterology category.

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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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