FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
APEX DAL ELECTRONIC APEX LOCATOR
K Number: K080113
·
Decision Feb 15, 2008
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
5
Review Days
30
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Basic Information
- Device Name
- APEX DAL ELECTRONIC APEX LOCATOR
- K Number
- K080113
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicnrg , Ltd.
- Date Received
- January 16, 2008
- Decision Date
- February 15, 2008
- Product Code
- LQY
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LQY | Locator, Root Apex | FDA unclassified | Unknown |
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