510(k) K032997
K032997 is an FDA 510(k) premarket notification submitted by Mennen Medical , Ltd. for the device "MODIFICATION TO: HORIZON 9000WS". The FDA issued a decision of Substantially Equivalent on October 15, 2003. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Mennen Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2003
- Date Received
- September 25, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Device Class
- Class II
- Regulation Number
- 870.1435
- Review Panel
- CV
- Submission Type