Microjet Crono
FDA 510(k) K013234 · Cane S.R.L.
510(k) numberK013234
Submission
- Device name
- Microjet Crono
- Applicant
- Cane S.R.L.
Deer Field, IL, US - Received
- September 27, 2001
- Decision date
- April 26, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K091042 | Crono S-Pid 50FRN · Special | 05/12/2009SE |
| K052218 | Crono Five and Crono Pca 50FRN · Traditional | 11/23/2005SE |
| K052219 | Crono Go.FRN · Special | 09/13/2005SE |
| K052217 | Crono Super PidFRN · Special | 09/13/2005SE |
| K042085 | Crono FFRN · Special | 09/17/2004SE |
| K041414 | Crono and Crono, Model 30FRN · Special | 07/08/2004SE |
| K013840 | Microjet Crono Par and Crono Apo-GoFRN · Traditional | 05/14/2002SE |
| K013822 | Microjet Crono PcaMEA · Traditional | 05/08/2002SE |
| K013807 | Microjet Quark, Model U100 or U40LZG · Traditional | 12/12/2001SE |
Questions and answers
When was Microjet Crono cleared by the FDA?
Microjet Crono (K013234) received a 510(k) decision of Substantially Equivalent on April 26, 2002, 211 days after the submission was received.
What is the product code of K013234?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.