FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
K Number: K102626
·
Decision Nov 12, 2010
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
76
Applicant Total
6
Review Days
60
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Basic Information
- Device Name
- VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01
- K Number
- K102626
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vega Technologies, Inc.
- Date Received
- September 13, 2010
- Decision Date
- November 12, 2010
- Product Code
- JCX
- 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 |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Vega Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102625 | VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 | Jun 10, 2011 | Substantially Equivalent |
| K102934 | INFRARED EAR THERMOMETER, MODEL IR-04MT | Jan 14, 2011 | Substantially Equivalent |
| K041516 | DIGITAL THERMOMETER, MODELS MT-XX8 AND MT-XX9 | Sep 8, 2004 | Substantially Equivalent |
| K031413 | VIGORMIST COMPRESSOR NEBULIZER | Oct 7, 2003 | Substantially Equivalent |
| K002831 | VEGA ULTRASONIC NEBULIZER | May 23, 2001 | Substantially Equivalent |