FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODEL 2100 PORTABLE FIELD UNIT
K Number: K911506
·
Decision Jun 24, 1991
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
3
Review Days
81
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Basic Information
- Device Name
- MODEL 2100 PORTABLE FIELD UNIT
- K Number
- K911506
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Dntl Corp.
- Date Received
- April 4, 1991
- Decision Date
- June 24, 1991
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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