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FDA 510(k)

ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)

K-Number: K073372 · 2007-12-07

ApplicantSystemsone
Decision Date2007-12-07
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) is the device name listed in this FDA 510(k) record. The listed applicant is Systemsone. It received FDA 510(k) clearance on 2007-12-07 under 510(k) number K073372. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)?

ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) is a medical device that received FDA 510(k) clearance on 2007-12-07. The listed applicant is Systemsone. The 510(k) number is K073372.

When did ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) receive FDA 510(k) clearance?

ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) received FDA 510(k) clearance on 2007-12-07, under 510(k) number K073372.

Who is the listed applicant for ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)?

The FDA 510(k) record lists Systemsone as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI)?

The FDA product code for ELECTROPHYSIOLOGY SYSTEMS INTEGRATOR (EPSI) is DXJ.

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Related Devices (Code: DXJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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