VARICOSCREEN(TM)
FDA 510(k) clearance K900404 · decided 1990-12-07
Clearance details
- K-number
- K900404
- Device name
- VARICOSCREEN(TM)
- Applicant
- Promedex, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-29
- Decision date
- 1990-12-07
- Days to decision
- 312 days
- Clearance type
- Traditional
- Product code
- KYA
- Device class
- 1
- Regulation number
- 884.2982
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Fort Woth, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BREAST THERMAL ACTIVITY INDICATOR (K832989) | Bcsi Laboratories, Inc. | 1984-01-17 |
| THERMAX; THERMAX SYSTEM (K823245) | American Thermometer Company, Inc. | 1982-11-16 |
| CHIROPRATIC INFRA-RED CRYSTAL PAK (K821524) | Dr. John D. Reid B.A., D.C. | 1982-09-08 |
| PARATHERM (K821049) | American Thermometer Company, Inc. | 1982-04-29 |
Recalls involving this device
No recalls on record reference this clearance.