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FDA 510(k)

RD-1200H NORMAL MODE RUBY LASER SYSTEM

K-Number: K955612 · 1996-07-09

ApplicantSpectrum Medical Technologies, Inc.
Decision Date1996-07-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RD-1200H NORMAL MODE RUBY LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical Technologies, Inc.. It received FDA 510(k) clearance on 1996-07-09 under 510(k) number K955612. 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 RD-1200H NORMAL MODE RUBY LASER SYSTEM?

RD-1200H NORMAL MODE RUBY LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-07-09. The listed applicant is Spectrum Medical Technologies, Inc.. The 510(k) number is K955612.

When did RD-1200H NORMAL MODE RUBY LASER SYSTEM receive FDA 510(k) clearance?

RD-1200H NORMAL MODE RUBY LASER SYSTEM received FDA 510(k) clearance on 1996-07-09, under 510(k) number K955612.

Who is the listed applicant for RD-1200H NORMAL MODE RUBY LASER SYSTEM?

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

What is the FDA product code for RD-1200H NORMAL MODE RUBY LASER SYSTEM?

The FDA product code for RD-1200H NORMAL MODE RUBY LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Spectrum Medical Technologies, 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.

K963947EPILASER NORMAL MODE RUBY LASERK910422MODEL RD-1200 RUBY LASER SYSTEM

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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