Bloom2 Programmable Electrophysiology Stimulator— 510(k) K173439
Substantially EquivalentFischer Medical
FDA 510(k) clearance K173439 for Bloom2 Programmable Electrophysiology Stimulator, Substantially Equivalent on 2018-03-29. Applicant: Fischer Medical. Device class: 2.
Clearance details
- Applicant
- Fischer Medical
- Product code
- Code JOQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1750
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wheat Ridge, CO, US
Recent devices under product code JOQ
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