510(k) K033211
K033211 is an FDA 510(k) premarket notification submitted by Endocardial Solutions, Inc. for the device "ENSITE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 30, 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
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2003
- Date Received
- October 3, 2003
- 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