FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CALEO
K Number: K003067
·
Decision Dec 13, 2000
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
8
Review Days
72
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Basic Information
- Device Name
- CALEO
- K Number
- K003067
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Drager Medizintechnik GmbH
- Date Received
- October 2, 2000
- Decision Date
- December 13, 2000
- Product Code
- FMZ
- 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
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Other Clearances by Drager Medizintechnik GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K023289 | OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 | Jan 15, 2003 | Substantially Equivalent |
| K010793 | OXYLOG 1000, MODEL 2M86840 | Dec 20, 2001 | Substantially Equivalent |
| K012177 | VENTVIEW, MODEL 8414095 | Sep 4, 2001 | Substantially Equivalent |
| K003068 | SAVINA | Jun 25, 2001 | Substantially Equivalent |
| K010093 | NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 | Jun 14, 2001 | Substantially Equivalent |
| K010724 | SOLA 700,SOLA 500, SOLA 300 | Jun 7, 2001 | Substantially Equivalent |
| K984611 | DRAGER SOLA SERIES, MODELS 1000/700/500/300 | Mar 29, 1999 | Substantially Equivalent |