FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313
K Number: K760519
·
Decision Sep 3, 1976
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
5
Applicant Total
5
Review Days
8
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Basic Information
- Device Name
- SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313
- K Number
- K760519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Dermatron Corp.
- Date Received
- August 26, 1976
- Decision Date
- September 3, 1976
- Product Code
- IOB
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IOB | Lamp, Infrared, Non Heating | FDA class 2 | Physical Medicine |
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Other Clearances by Dermatron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K770862 | BLACK LAMPS,F72T12/BL/HO | Jun 27, 1977 | Substantially Equivalent |
| K761094 | UVA PHOTOTHERAPY SYSTEM | Dec 2, 1976 | Substantially Equivalent |
| K760471 | LAMP, FLOURESCENT BLACK, HIGH OUTPUT | Sep 15, 1976 | Substantially Equivalent |
| K760482 | SUNLAMP (F40-UVB & F20-UVB) | Sep 15, 1976 | Substantially Equivalent |