Bloom2 Programmable Electrophysiology Stimulator
K-Number: K173439 · 2018-03-29
ApplicantFischer Medical
Decision Date2018-03-29
Product CodeJOQ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Bloom2 Programmable Electrophysiology Stimulator is a medical device manufactured by Fischer Medical. It received FDA 510(k) clearance on 2018-03-29 under approval number K173439. The device is classified under product code JOQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bloom2 Programmable Electrophysiology Stimulator?
Bloom2 Programmable Electrophysiology Stimulator is a medical device that received FDA 510(k) clearance on 2018-03-29. It is manufactured by Fischer Medical. The 510(k) number is K173439.
When was Bloom2 Programmable Electrophysiology Stimulator approved by the FDA?
Bloom2 Programmable Electrophysiology Stimulator received FDA 510(k) clearance on 2018-03-29, under approval number K173439.
What company makes Bloom2 Programmable Electrophysiology Stimulator?
Bloom2 Programmable Electrophysiology Stimulator is manufactured by Fischer Medical.
What is the FDA product code for Bloom2 Programmable Electrophysiology Stimulator?
The FDA product code for Bloom2 Programmable Electrophysiology Stimulator is JOQ.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.