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FDA 510(k)

(HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2

K-Number: K885181 · 1989-01-10

ApplicantHeraeus Lasersonics, Inc.
Decision Date1989-01-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

(HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Lasersonics, Inc.. It received FDA 510(k) clearance on 1989-01-10 under 510(k) number K885181. 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 (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2?

(HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 is a medical device that received FDA 510(k) clearance on 1989-01-10. The listed applicant is Heraeus Lasersonics, Inc.. The 510(k) number is K885181.

When did (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 receive FDA 510(k) clearance?

(HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 received FDA 510(k) clearance on 1989-01-10, under 510(k) number K885181.

Who is the listed applicant for (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2?

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

What is the FDA product code for (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2?

The FDA product code for (HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO2 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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