← Product Code [BTI](/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI) · K850795

# AIR COMPRESSOR (K850795)

_Bear Medical Systems, Inc. · BTI · May 28, 1985 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K850795

## Device Facts

- **Applicant:** Bear Medical Systems, Inc.
- **Product Code:** [BTI](/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI.md)
- **Decision Date:** May 28, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.6250
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K850795](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K850795)

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