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FDA 510(k)

DORNIER MEDILAS R

K-Number: K984349 · 1999-02-04

ApplicantDornier
Decision Date1999-02-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DORNIER MEDILAS R is the device name listed in this FDA 510(k) record. The listed applicant is Dornier. It received FDA 510(k) clearance on 1999-02-04 under 510(k) number K984349. 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 MEDILAS R?

DORNIER MEDILAS R is a medical device that received FDA 510(k) clearance on 1999-02-04. The listed applicant is Dornier. The 510(k) number is K984349.

When did DORNIER MEDILAS R receive FDA 510(k) clearance?

DORNIER MEDILAS R received FDA 510(k) clearance on 1999-02-04, under 510(k) number K984349.

Who is the listed applicant for DORNIER MEDILAS R?

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

What is the FDA product code for DORNIER MEDILAS R?

The FDA product code for DORNIER MEDILAS R is GEX. This falls under the Gastroenterology category.

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Other records listing Dornier 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.

K011873DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)K011773DORNIER LITHOTRIPTER 140(DOLI 140)

Related Devices (Code: GEX)

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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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