← Product Code [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM) · K002846

# HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR (K002846)

_Headstar Medical Products Co., Ltd. · BTM · Jun 6, 2001 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K002846

## Device Facts

- **Applicant:** Headstar Medical Products Co., Ltd.
- **Product Code:** [BTM](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM.md)
- **Decision Date:** Jun 6, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5915
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K002846](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTM/K002846)

**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