FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
FORAMATRON IV
K Number: K950857
·
Decision Apr 20, 1995
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
53
Review Days
52
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Basic Information
- Device Name
- FORAMATRON IV
- K Number
- K950857
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Parkell, Inc.
- Date Received
- February 27, 1995
- Decision Date
- April 20, 1995
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQY), ordered by most recent decision date.
Apex Locator (FindPex)
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
Electronic Apex Locator (Alpha Apex I)
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
FDA 510(k)
FDA Unclassified
·Unknown
Root Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
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