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FDA 510(k)

EPI CARDIA SYS. - AMBULATORY MONITOR

K-Number: K830013 · 1983-02-28

ApplicantMedicomp, Inc.
Decision Date1983-02-28
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPI CARDIA SYS. - AMBULATORY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Medicomp, Inc.. It received FDA 510(k) clearance on 1983-02-28 under 510(k) number K830013. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPI CARDIA SYS. - AMBULATORY MONITOR?

EPI CARDIA SYS. - AMBULATORY MONITOR is a medical device that received FDA 510(k) clearance on 1983-02-28. The listed applicant is Medicomp, Inc.. The 510(k) number is K830013.

When did EPI CARDIA SYS. - AMBULATORY MONITOR receive FDA 510(k) clearance?

EPI CARDIA SYS. - AMBULATORY MONITOR received FDA 510(k) clearance on 1983-02-28, under 510(k) number K830013.

Who is the listed applicant for EPI CARDIA SYS. - AMBULATORY MONITOR?

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 EPI CARDIA SYS. - AMBULATORY MONITOR?

The FDA product code for EPI CARDIA SYS. - AMBULATORY MONITOR is DSI.

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Related Devices (Code: DSI)

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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