Bloom2 Programmable Electrophysiology Stimulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173439 FDA 510(k)
- FDA Product Code
- JOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1750 FDA 510(k)
- Regulation Number
- 870.1750 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bloom2 Programmable Electrophysiology Stimulator is a programmable, electrical, pulse generator intended to provide diagnostic, electrical, cardiac stimulation. It is designed for use in electrophysiology testing during electrophysiology procedures.
The device is intended for use in the electrophysiology laboratory during electrophysiology testing, under the direction of qualified personnel trained to administer electrophysiology procedures. It has received FDA 510(k) clearance under K173439 and is classified as a Class II device for cardiovascular use.
Frequently asked questions
What is the Bloom2 Programmable Electrophysiology Stimulator used for?
The Bloom2 Programmable Electrophysiology Stimulator is intended to provide diagnostic electrical cardiac stimulation during electrophysiology testing procedures. It is used in the electrophysiology laboratory under the direction of qualified personnel trained to administer such procedures, as it delivers programmable electrical pulses to assess cardiac function.
Is the Bloom2 Programmable Electrophysiology Stimulator reusable or single-use?
The Bloom2 Programmable Electrophysiology Stimulator is a reusable external pulse generator designed for multiple uses in clinical settings. It is not a single-use device; instead, it is intended for repeated application during electrophysiology procedures, provided it is properly maintained and operated according to manufacturer guidelines.
What regulatory pathway was used for the Bloom2 Programmable Electrophysiology Stimulator?
The Bloom2 Programmable Electrophysiology Stimulator received FDA 510(k) clearance under submission number K173439, which demonstrates substantial equivalence to a legally marketed predicate device. This traditional 510(k) pathway was used for its Class II classification in cardiovascular applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Products | Fischer Medical, Electrophysiology Stimulators Manufacturer | Fischer Medical, Bloom2 Programmable Electrophysiology Stimulator (K173439) — FDA 510 (k ..., K173439 FDA 510(k) - Bloom2 Programmable Electrophysiology S...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173439 | Class II | Active |
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Manufacturer
- Manufacturer
- Fischer Medical
Sources (1)
- FDA 510(k) K173439 24 fields · synced Sep 28, 2026