510(k) K011826
K011826 is an FDA 510(k) premarket notification submitted by Micropace Pty, Ltd. for the device "EPS320 CARDIAC STIMULATOR". The FDA issued a decision of Substantially Equivalent on January 24, 2002. 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. Micropace Pty, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 2002
- Date Received
- June 11, 2001
- Clearance Type
- Traditional
- 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