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FDA 510(k)

TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM

K-Number: K905708 · 1991-03-28

ApplicantTrimedyne, Inc.
Decision Date1991-03-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1991-03-28 under 510(k) number K905708. 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 MODEL 1210 OMNIPULSE LASER SYSTEM?

TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-03-28. The listed applicant is Trimedyne, Inc.. The 510(k) number is K905708.

When did TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM receive FDA 510(k) clearance?

TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM received FDA 510(k) clearance on 1991-03-28, under 510(k) number K905708.

Who is the listed applicant for TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM?

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 MODEL 1210 OMNIPULSE LASER SYSTEM?

The FDA product code for TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Trimedyne, Inc. as applicant

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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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