The following data is part of a premarket notification filed by Fischer Medical with the FDA for Bloom2 Programmable Electrophysiology Stimulator.
| Device ID | K173439 |
| 510k Number | K173439 |
| Device Name: | Bloom2 Programmable Electrophysiology Stimulator |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | Fischer Medical 3990 Youngfield Street Wheat Ridge, CO 80033 |
| Contact | Wes Rogers |
| Correspondent | Charles Mike Hart HART Consulting LLC 615 Reid Place Castle Rock, CO 80108 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-03 |
| Decision Date | 2018-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863019000351 | K173439 | 000 |
| 00863019000344 | K173439 | 000 |
| 00863019000337 | K173439 | 000 |
| 00863019000368 | K173439 | 000 |