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FDA 510(k)

DORNIER MEDILA H

K-Number: K983963 · 1998-11-25

ApplicantDornier Medtech America, Inc.
Decision Date1998-11-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DORNIER MEDILA H is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 1998-11-25 under 510(k) number K983963. 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 DORNIER MEDILA H?

DORNIER MEDILA H is a medical device that received FDA 510(k) clearance on 1998-11-25. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K983963.

When did DORNIER MEDILA H receive FDA 510(k) clearance?

DORNIER MEDILA H received FDA 510(k) clearance on 1998-11-25, under 510(k) number K983963.

Who is the listed applicant for DORNIER MEDILA H?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DORNIER MEDILA H?

The FDA product code for DORNIER MEDILA H is GEX. This falls under the Gastroenterology category.

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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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