← Product Code [BZC](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC) · K801597 # PFT CALIBRATOR (K801597) _Spital Medical, Inc. · BZC · Aug 4, 1980 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K801597 ## Device Facts - **Applicant:** Spital Medical, Inc. - **Product Code:** [BZC](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC.md) - **Decision Date:** Aug 4, 1980 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.1880 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Regulatory Identification A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K801597](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K801597) **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/BZC/K801597