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 the device name listed in this FDA 510(k) record. The listed applicant is Fischer Medical. It received FDA 510(k) clearance on 2018-03-29 under 510(k) 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. The listed applicant is Fischer Medical. The 510(k) number is K173439.
When did Bloom2 Programmable Electrophysiology Stimulator receive FDA 510(k) clearance?
Bloom2 Programmable Electrophysiology Stimulator received FDA 510(k) clearance on 2018-03-29, under 510(k) number K173439.
Who is the listed applicant for Bloom2 Programmable Electrophysiology Stimulator?
The FDA 510(k) record lists Fischer Medical as the applicant. This does not by itself establish the device manufacturer.
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.