FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYLVAN PEDIASCAN 200 TRANSILLUMINATOR
K Number: K901309
·
Decision May 24, 1990
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
2
Applicant Total
1
Review Days
65
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Basic Information
- Device Name
- SYLVAN PEDIASCAN 200 TRANSILLUMINATOR
- K Number
- K901309
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1945
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Sylvan Corp.
- Date Received
- March 20, 1990
- Decision Date
- May 24, 1990
- 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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