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FDA 510(k)

MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM

K-Number: K901340 · 1990-06-26

ApplicantKlinger Medical
Decision Date1990-06-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Klinger Medical. It received FDA 510(k) clearance on 1990-06-26 under 510(k) number K901340. 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 MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM?

MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1990-06-26. The listed applicant is Klinger Medical. The 510(k) number is K901340.

When did MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM receive FDA 510(k) clearance?

MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM received FDA 510(k) clearance on 1990-06-26, under 510(k) number K901340.

Who is the listed applicant for MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM?

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

What is the FDA product code for MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM?

The FDA product code for MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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