CRONO F
FDA 510(k) clearance K042085 · decided 2004-09-17
Clearance details
- K-number
- K042085
- Device name
- CRONO F
- Applicant
- Cane S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2004-08-03
- Decision date
- 2004-09-17
- Days to decision
- 45 days
- Clearance type
- Special
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle" recall (Z-0099-2015) | Intra Pump Infusion Systems | 2014-10-21 |