FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOLA 700,SOLA 500, SOLA 300
K Number: K010724
·
Decision Jun 7, 2001
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
28
Applicant Total
8
Review Days
87
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Basic Information
- Device Name
- SOLA 700,SOLA 500, SOLA 300
- K Number
- K010724
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Drager Medizintechnik GmbH
- Date Received
- March 12, 2001
- Decision Date
- June 7, 2001
- Product Code
- FTD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FTD | Lamp, Surgical | FDA class 2 | General, Plastic Surgery |
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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 |
| K003067 | CALEO | Dec 13, 2000 | Substantially Equivalent |
| K984611 | DRAGER SOLA SERIES, MODELS 1000/700/500/300 | Mar 29, 1999 | Substantially Equivalent |