← Product Code [DXG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG) · K790047 # CARDIAC OUTPUT COMPUTER, MDEL 9520A (K790047) _Edwards Laboratories · DXG · Feb 26, 1979 · Cardiovascular · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K790047 ## Device Facts - **Applicant:** Edwards Laboratories - **Product Code:** [DXG](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG.md) - **Decision Date:** Feb 26, 1979 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 870.1435 - **Device Class:** Class 2 - **Review Panel:** Cardiovascular ## Regulatory Identification A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices. --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K790047](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K790047) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXG/K790047