FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540
K Number: K092537
·
Decision Aug 27, 2009
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
1
Review Days
8
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Basic Information
- Device Name
- DIGITAL X-RAY SENSOR, MODEL E9539,E9505,E9502, E9540
- K Number
- K092537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Toshiba America Electronic Components, Inc.
- Date Received
- August 19, 2009
- Decision Date
- August 27, 2009
- Product Code
- MUH
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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