FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMS AIR-FLOW MASTER PIEZON
K Number: K110173
·
Decision Apr 7, 2011
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
191
Applicant Total
5
Review Days
77
Basic Information
- Device Name
- EMS AIR-FLOW MASTER PIEZON
- K Number
- K110173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EMS ELECTRO MEDICAL SYSTEMS SA
- Date Received
- January 20, 2011
- Decision Date
- April 7, 2011
- Product Code
- ELC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
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