Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EPICARDIA 4000

K-Number: K900207 · 1990-07-31

ApplicantMedicomp, Inc.
Decision Date1990-07-31
Product CodeDST
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPICARDIA 4000 is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 1990-07-31 under 510(k) number K900207. The device is classified under product code DST. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPICARDIA 4000?

EPICARDIA 4000 is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Medicomp, Inc.. The 510(k) number is K900207.

When did EPICARDIA 4000 receive FDA 510(k) clearance?

EPICARDIA 4000 received FDA 510(k) clearance on 1990-07-31, under 510(k) number K900207.

Who is the listed applicant for EPICARDIA 4000?

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

What is the FDA product code for EPICARDIA 4000?

The FDA product code for EPICARDIA 4000 is DST.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medicomp, Inc. as applicant

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.

K173170Epicardia AnywhereK161916TelePatch Cardiac MonitorK091696SAVI WIRELESS, MODEL PM500K090834EPICARDIA 5000K043454CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410K981119CARDIOPAL MODEL NUMBER PM20

View all 23 devices →

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.

↑