FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LULMITEX NEONATAL TRANSILLUMINATOR
K Number: K912747
·
Decision Dec 24, 1991
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
2
Applicant Total
3
Review Days
186
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Basic Information
- Device Name
- LULMITEX NEONATAL TRANSILLUMINATOR
- K Number
- K912747
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1945
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lumitex, Inc.
- Date Received
- June 21, 1991
- Decision Date
- December 24, 1991
- Product Code
- HJN
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HJN | Transilluminator, Battery-Powered | FDA class 1 | Ophthalmic |
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