The following data is part of a premarket notification filed by Heartware Intl. Corp. with the FDA for Hb 1000, Brugada Electrophysiology System.
| Device ID | K893094 |
| 510k Number | K893094 |
| Device Name: | HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | HEARTWARE INTL. CORP. 2901 BROADWAY SUITE 118 New York, NY 10025 |
| Contact | Gerald B Seery |
| Correspondent | Gerald B Seery HEARTWARE INTL. CORP. 2901 BROADWAY SUITE 118 New York, NY 10025 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-28 |
| Decision Date | 1989-10-02 |