510(k) K900404
- Device
- VARICOSCREEN(TM)
- Applicant
- PROMEDEX, INC.
- 510(k) number
- K900404
- Product code
- KYA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-12-07
- Date received
- 1990-01-29
- Regulation
- 884.2982
- Classification name
- System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD A HAMER
- Address
- C/O Richard Hamer Assoc.Inc. P.O.Box 16598 Fort Woth TX US 76162 76162
FDA Registration Numbers#
- 2247290
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KYA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832989 | BREAST THERMAL ACTIVITY INDICATOR | Bcsi Laboratories, Inc. | 1984-01-17 |
| K823245 | THERMAX; THERMAX SYSTEM | American Thermometer Company, Inc. | 1982-11-16 |
| K821524 | CHIROPRATIC INFRA-RED CRYSTAL PAK | Dr. John D. Reid B.A., D.C. | 1982-09-08 |
| K821049 | PARATHERM | American Thermometer Company, Inc. | 1982-04-29 |
Legacy Summary#
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FDA Review#
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