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FDA 510(k)

COOL.CLICK 2

K-Number: K060819 · 2006-06-16

ApplicantMedical House Products Limited
Decision Date2006-06-16
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COOL.CLICK 2 is the device name listed in this FDA 510(k) record. The listed applicant is Medical House Products Limited. It received FDA 510(k) clearance on 2006-06-16 under 510(k) number K060819. The device is classified under product code KZE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOL.CLICK 2?

COOL.CLICK 2 is a medical device that received FDA 510(k) clearance on 2006-06-16. The listed applicant is Medical House Products Limited. The 510(k) number is K060819.

When did COOL.CLICK 2 receive FDA 510(k) clearance?

COOL.CLICK 2 received FDA 510(k) clearance on 2006-06-16, under 510(k) number K060819.

Who is the listed applicant for COOL.CLICK 2?

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

What is the FDA product code for COOL.CLICK 2?

The FDA product code for COOL.CLICK 2 is KZE.

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Other records listing Medical House Products Limited 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.

K082587AUTO-SAFETY INJECTOR-2 (ASI-2)

Related Devices (Code: KZE)

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.

K121270BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEMBioject Medical Technologies, Inc.K111517PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIPharmajet, Inc.K110456PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.K090959LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RAD'Antonio Consultants International, Inc. (Dci)K090003ZETAJETBioject, Inc.K081532PHARMAJET NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.

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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