← Product Code [BZM](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM) · K801496 # PULMONARY LAB AUTOMATION SYSTEM (K801496) _Medical Graphics Corp. · BZM · Jul 21, 1980 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K801496 ## Device Facts - **Applicant:** Medical Graphics Corp. - **Product Code:** [BZM](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM.md) - **Decision Date:** Jul 21, 1980 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1900 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Regulatory Identification A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K801496](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K801496) **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/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K801496