510(k) K760519
- Device
- SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313
- Applicant
- DERMATRON CORP.
- 510(k) number
- K760519
- Product code
- IOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-09-03
- Date received
- 1976-08-26
- Regulation
- 890.5500
- Classification name
- Lamp, Infrared, Non Heating
- Medical specialty
- Physical Medicine
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IOB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K903660 | DERMALIGHT PSORACOMB | Solitec GmbH | 1991-07-17 |
| K910091 | ULTRALITE PANELITE | Ultralite | 1991-05-30 |
| K842276 | SUNMASTER | Mt. Hood Mfr., Inc. | 1984-07-16 |
| K813451 | UVA FLUORESCENT TANNING LAMPS | North American Philips Corp. | 1982-01-28 |
| K812853 | OSRAM UVA LAMP | Osram GmbH | 1981-12-09 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases