510(k) K043564
K043564 is an FDA 510(k) premarket notification submitted by Mennen Medical , Ltd. for the device "HORIZON ANGIO CATHLAB". The FDA issued a decision of Substantially Equivalent on January 27, 2005. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Mennen Medical , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2005
- Date Received
- December 27, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type