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FDA 510(k)

PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X

K-Number: K002228 · 2000-10-06

ApplicantParadigm Medical Industries, Inc.
Decision Date2000-10-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Medical Industries, Inc.. It received FDA 510(k) clearance on 2000-10-06 under 510(k) number K002228. 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 PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X?

PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X is a medical device that received FDA 510(k) clearance on 2000-10-06. The listed applicant is Paradigm Medical Industries, Inc.. The 510(k) number is K002228.

When did PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X receive FDA 510(k) clearance?

PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X received FDA 510(k) clearance on 2000-10-06, under 510(k) number K002228.

Who is the listed applicant for PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X?

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

What is the FDA product code for PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X?

The FDA product code for PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X is GEX. This falls under the Gastroenterology category.

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Other records listing Paradigm Medical Industries, 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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