← Product Code [BZM](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM) · K863953

# SPIROMETRICS MODEL 2500 FLOWMATE(TM) (K863953)

_Spirometrics, Inc. · BZM · Jan 15, 1987 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K863953

## Device Facts

- **Applicant:** Spirometrics, Inc.
- **Product Code:** [BZM](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM.md)
- **Decision Date:** Jan 15, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1900
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K863953](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K863953)

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