← Product Code [BZM](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM) · K874902

# SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY (K874902)

_Gomi Medical Instruments · BZM · Jun 7, 1988 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K874902

## Device Facts

- **Applicant:** Gomi Medical Instruments
- **Product Code:** [BZM](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM.md)
- **Decision Date:** Jun 7, 1988
- **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/K874902](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZM/K874902)

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