← Product Code [BSZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ) · K864590

# AM1000 (K864590)

_Bear Medical Systems, Inc. · BSZ · May 4, 1987 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K864590

## Device Facts

- **Applicant:** Bear Medical Systems, Inc.
- **Product Code:** [BSZ](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ.md)
- **Decision Date:** May 4, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5160
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K864590](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BSZ/K864590)

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