← Product Code [BZC](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC) · K810751

# PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF (K810751)

_General Electric Co. · BZC · Apr 10, 1981 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K810751

## Device Facts

- **Applicant:** General Electric Co.
- **Product Code:** [BZC](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC.md)
- **Decision Date:** Apr 10, 1981
- **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/K810751](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZC/K810751)

**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:** Innolitics at https://innolitics.com