← Product Code [BTK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK) · K944949

# GENERAL ANESTHESIA SYSTEM (K944949)

_Vital Signs, Inc. · BTK · Nov 14, 1994 · Anesthesiology · SESK_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK/K944949

## Device Facts

- **Applicant:** Vital Signs, Inc.
- **Product Code:** [BTK](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK.md)
- **Decision Date:** Nov 14, 1994
- **Decision:** SESK
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5560
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

A gas mask head strap is a device used to hold an anesthetic gas mask in position on a patient's face.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK/K944949](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BTK/K944949)

**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
