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FDA 510(k)

DIOLITE 532

K-Number: K964074 · 1997-04-01

ApplicantIriderm Div.
Decision Date1997-04-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIOLITE 532 is the device name listed in this FDA 510(k) record. The listed applicant is Iriderm Div.. It received FDA 510(k) clearance on 1997-04-01 under 510(k) number K964074. 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 DIOLITE 532?

DIOLITE 532 is a medical device that received FDA 510(k) clearance on 1997-04-01. The listed applicant is Iriderm Div.. The 510(k) number is K964074.

When did DIOLITE 532 receive FDA 510(k) clearance?

DIOLITE 532 received FDA 510(k) clearance on 1997-04-01, under 510(k) number K964074.

Who is the listed applicant for DIOLITE 532?

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

What is the FDA product code for DIOLITE 532?

The FDA product code for DIOLITE 532 is GEX. This falls under the Gastroenterology category.

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Other records listing Iriderm Div. as applicant

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Related Devices (Code: GEX)

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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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