510(k) K040207
K040207 is an FDA 510(k) premarket notification submitted by Ep Medsystems for the device "EP-4 CLINICAL STIMULATOR". The FDA issued a decision of Substantially Equivalent on February 27, 2004. The device falls under product code JOQ (Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)), a Class II device regulated under 21 CFR 870.1750. Ep Medsystems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2004
- Date Received
- January 30, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- Device Class
- Class II
- Regulation Number
- 870.1750
- Review Panel
- CV
- Submission Type