FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE 900
K Number: K811103
·
Decision Jun 9, 1981
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
254
Review Days
47
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Basic Information
- Device Name
- GE 900
- K Number
- K811103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- General Electric Co.
- Date Received
- April 23, 1981
- Decision Date
- June 9, 1981
- Product Code
- EHD
- Advisory Committee
- Dental
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
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