510(k) K893094
K893094 is an FDA 510(k) premarket notification submitted by Heartware Intl. Corp. for the device "HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 2, 1989. 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. Heartware Intl. Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1989
- Date Received
- April 28, 1989
- 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