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FDA 510(k)

RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES

K-Number: K071621 · 2007-10-09

ApplicantReliant Technologies, Inc.
Decision Date2007-10-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Reliant Technologies, Inc.. It received FDA 510(k) clearance on 2007-10-09 under 510(k) number K071621. 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 RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES?

RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2007-10-09. The listed applicant is Reliant Technologies, Inc.. The 510(k) number is K071621.

When did RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2007-10-09, under 510(k) number K071621.

Who is the listed applicant for RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES?

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

What is the FDA product code for RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES?

The FDA product code for RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES 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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