510(k) K900404
K900404 is an FDA 510(k) premarket notification submitted by Promedex, Inc. for the device "VARICOSCREEN(TM)". The FDA issued a decision of Substantially Equivalent on December 7, 1990. The device falls under product code KYA (System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2982. Promedex, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1990
- Date Received
- January 29, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)
- Device Class
- Class I
- Regulation Number
- 884.2982
- Review Panel
- RA
- Submission Type