Cool.Click 2
FDA 510(k) K060819 · Medical House Products Limited
510(k) numberK060819
Submission
- Device name
- Cool.Click 2
- Applicant
- Medical House Products Limited
Sheffield, GB - Received
- March 27, 2006
- Decision date
- June 16, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KZE – Injector, Fluid, Non-Electrically Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5430
- Specialty
- General Hospital
Other 510(k)s with product code KZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121270 | Bioject Needle-Free Injection Management SystemKZE · Traditional | Bioject Medical Technologies, Inc. | 07/19/2012SE |
| K111517 | Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…KZE · Special | Pharmajet, Inc. | 07/27/2011SE |
| K110456 | Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemKZE · Traditional | Pharmajet, Inc. | 03/02/2011SE |
| K090959 | Lectrajet Needle-Free Injection System, Model: M3 RaKZE · Traditional | D'Antonio Consultants International, Inc. (Dci) | 12/24/2009SE |
| K090003 | ZetajetKZE · Abbreviated | Bioject, Inc. | 04/02/2009SE |
| K081532 | Pharmajet Needle-Free Injection SystemKZE · Traditional | Pharmajet, Inc. | 02/26/2009SE |
| K082138 | Airgent, Model AG7000010KZE · Traditional | Perfaction, Inc. | 01/23/2009SE |
| K051985 | Biovalve Mini-Ject Needlefree InjectorKZE · Special | Biovalve Technologies, Inc. | 08/17/2005SE |
| K050734 | Cool.ClickKZE · Traditional | Bioject, Inc. | 06/03/2005SE |
| K041239 | Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000KZE · Traditional | Genesis Medical Technology, Inc. | 11/08/2004SE |
More from Genesis Medical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082587 | Auto-Safety INJECTOR-2 (ASI-2)KZH · Traditional | 10/02/2008SE |
Questions and answers
When was Cool.Click 2 cleared by the FDA?
Cool.Click 2 (K060819) received a 510(k) decision of Substantially Equivalent on June 16, 2006, 81 days after the submission was received.
What is the product code of K060819?
The FDA product code is KZE – Injector, Fluid, Non-Electrically Powered, a Class II (moderate risk) device regulated under 21 CFR 880.5430.