← Product Code [PHZ](/productcode/PHZ) · K260140

# Aevice Wheeze Detection Module (K260140)

_Aevice Health Pte. , Ltd. · PHZ · Sep 25, 2026 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260140

## Device Facts

- **Applicant:** Aevice Health Pte. , Ltd.
- **Product Code:** [PHZ](/productcode/PHZ.md)
- **Decision Date:** Sep 25, 2026
- **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/device/K260140](https://fda.innolitics.com/device/K260140)

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