510(k) K854203
K854203 is an FDA 510(k) premarket notification submitted by Tecnomed, Inc. for the device "TEC 2720 MAMEX DC MAG". The FDA issued a decision of Substantially Equivalent on Mar 6, 1986. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Tecnomed, Inc. has 17 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 6, 1986
- Date Received
- Oct 16, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mammographic
- Device Class
- Class II
- Regulation Number
- 892.1710
- Review Panel
- RA
- Submission Type
- 510(k)