← Product Code [IMF](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF) · K900419

# CRYOTRON-UL30 (K900419)

_Henley Intl. · IMF · Feb 27, 1990 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF/K900419

## Device Facts

- **Applicant:** Henley Intl.
- **Product Code:** [IMF](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF.md)
- **Decision Date:** Feb 27, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5940
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory Identification

A chilling unit is a refrigerative device intended for medical purposes to chill and maintain cold packs at a reduced temperature.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF/K900419](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/IMF/K900419)

**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