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FDA 510(k)

JUNIPER COOLING DEVICE

K-Number: K060407 · 2006-05-31

ApplicantJuniper Medical Technology, Inc.
Decision Date2006-05-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JUNIPER COOLING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Juniper Medical Technology, Inc.. It received FDA 510(k) clearance on 2006-05-31 under 510(k) number K060407. 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 JUNIPER COOLING DEVICE?

JUNIPER COOLING DEVICE is a medical device that received FDA 510(k) clearance on 2006-05-31. The listed applicant is Juniper Medical Technology, Inc.. The 510(k) number is K060407.

When did JUNIPER COOLING DEVICE receive FDA 510(k) clearance?

JUNIPER COOLING DEVICE received FDA 510(k) clearance on 2006-05-31, under 510(k) number K060407.

Who is the listed applicant for JUNIPER COOLING DEVICE?

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

What is the FDA product code for JUNIPER COOLING DEVICE?

The FDA product code for JUNIPER COOLING DEVICE is GEX. This falls under the Gastroenterology category.

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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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