510(k) K030129
K030129 is an FDA 510(k) premarket notification submitted by Endocardial Solutions, Inc. for the device "MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000". The FDA issued a decision of SESU on April 22, 2003. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Endocardial Solutions, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- April 22, 2003
- Date Received
- January 14, 2003
- Clearance Type
- Traditional
- 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