← Product Code [BTY](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY) · K850045

# SPIROMETRICS 2453 & SMI III (K850045)

_Spirometrics, Inc. · BTY · Feb 14, 1985 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K850045

## Device Facts

- **Applicant:** Spirometrics, Inc.
- **Product Code:** [BTY](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY.md)
- **Decision Date:** Feb 14, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1890
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K850045](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BTY/K850045)

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