Medajet XL - Jet Injector
FDA 510(k) K850754 · Mada Medical Products, Inc.
510(k) numberK850754
Submission
- Device name
- Medajet XL - Jet Injector
- Applicant
- Mada Medical Products, Inc.
Carlstadt, NJ, US - Received
- February 25, 1985
- Decision date
- December 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K060819 | Cool.Click 2KZE · Traditional | Medical House Products Limited | 06/16/2006SE |
| K051985 | Biovalve Mini-Ject Needlefree InjectorKZE · Special | Biovalve Technologies, Inc. | 08/17/2005SE |
| K050734 | Cool.ClickKZE · Traditional | Bioject, Inc. | 06/03/2005SE |
More from Bioject, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003862 | Mada WheelchairsIOR · Traditional | 01/12/2001SE |
| K002943 | Wheelchair, Mechanical Series Model 3100IOR · Traditional | 10/23/2000SE |
| K950777 | Oxygen RegulatorCAN · Traditional | 04/14/1995SE |
| K930949 | VoyageCAF · Traditional | 06/01/1993SE |
| K930947 | PromenadeCAF · Traditional | 06/01/1993SE |
| K921611 | Madavac 190BTA · Traditional | 09/09/1992SE |
| K802426 | RESPO2 Oxygen ConcentratorCAW · Traditional | 10/23/1980SE |
Questions and answers
When was Medajet XL - Jet Injector cleared by the FDA?
Medajet XL - Jet Injector (K850754) received a 510(k) decision of Substantially Equivalent on December 10, 1985, 288 days after the submission was received.
What is the product code of K850754?
The FDA product code is KZE – Injector, Fluid, Non-Electrically Powered, a Class II (moderate risk) device regulated under 21 CFR 880.5430.