FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
CRONO FIVE AND CRONO PCA 50
K Number: K052218
·
Decision Nov 23, 2005
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
10
Review Days
100
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Basic Information
- Device Name
- CRONO FIVE AND CRONO PCA 50
- K Number
- K052218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cane S.R.L.
- Date Received
- August 15, 2005
- Decision Date
- November 23, 2005
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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Other Clearances by Cane S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K091042 | CRONO S-PID 50 | May 12, 2009 | Substantially Equivalent |
| K052219 | CRONO GO. | Sep 13, 2005 | Substantially Equivalent |
| K052217 | CRONO SUPER PID | Sep 13, 2005 | Substantially Equivalent |
| K042085 | CRONO F | Sep 17, 2004 | Substantially Equivalent |
| K041414 | CRONO AND CRONO, MODEL 30 | Jul 8, 2004 | Substantially Equivalent |
| K013840 | MICROJET CRONO PAR AND CRONO APO-GO | May 14, 2002 | Substantially Equivalent |
| K013822 | MICROJET CRONO PCA | May 8, 2002 | Substantially Equivalent |
| K013234 | MICROJET CRONO | Apr 26, 2002 | Substantially Equivalent |
| K013807 | MICROJET QUARK, MODEL U100 OR U40 | Dec 12, 2001 | Substantially Equivalent |