← Product Code [LHE](/productcode/LHE) · P790028

# BIOSTATOR GCIIS (P790028)

_Bayer Healthcare · LHE · Dec 4, 1980 · General Hospital · APWD_

**Canonical URL:** https://fda.innolitics.com/device/P790028

## Device Facts

- **Applicant:** Bayer Healthcare
- **Product Code:** [LHE](/productcode/LHE.md)
- **Decision Date:** Dec 4, 1980
- **Decision:** APWD
- **Device Class:** Class 3
- **Review Panel:** General Hospital

---

**Source:** [https://fda.innolitics.com/device/P790028](https://fda.innolitics.com/device/P790028)

**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 PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [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