FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITEST
K Number: K950237
·
Decision Jun 9, 1995
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
21
Applicant Total
53
Review Days
140
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Basic Information
- Device Name
- DIGITEST
- K Number
- K950237
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1720
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Parkell, Inc.
- Date Received
- January 20, 1995
- Decision Date
- June 9, 1995
- Product Code
- EAT
- 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 |
|---|---|---|---|
| EAT | Tester, Pulp | FDA class 2 | Dental |
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