← Product Code [BYD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD) · K852601

# SERVO HUMIDIFIER 153 (K852601)

_Siemens Elema AB · BYD · Jul 8, 1985 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K852601

## Device Facts

- **Applicant:** Siemens Elema AB
- **Product Code:** [BYD](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD.md)
- **Decision Date:** Jul 8, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5375
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K852601](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BYD/K852601)

**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
