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FDA 510(k)

JUNIPER COOLING DEVICE XTRA

K-Number: K063715 · 2007-02-05

ApplicantJuniper Medical, Inc.
Decision Date2007-02-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

JUNIPER COOLING DEVICE XTRA is the device name listed in this FDA 510(k) record. The listed applicant is Juniper Medical, Inc.. It received FDA 510(k) clearance on 2007-02-05 under 510(k) number K063715. 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 XTRA?

JUNIPER COOLING DEVICE XTRA is a medical device that received FDA 510(k) clearance on 2007-02-05. The listed applicant is Juniper Medical, Inc.. The 510(k) number is K063715.

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

JUNIPER COOLING DEVICE XTRA received FDA 510(k) clearance on 2007-02-05, under 510(k) number K063715.

Who is the listed applicant for JUNIPER COOLING DEVICE XTRA?

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

What is the FDA product code for JUNIPER COOLING DEVICE XTRA?

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

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Other records listing Juniper Medical, Inc. 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.

K072152JUNIPER CLN1 DERMAL COOLING DEVICE

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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.

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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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