← FDA Medical Device Classifications
Abnormal Breath Sound Device
PHZ · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.1900
Classification
- FDA Product Code
PHZ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 868.1900
- Review panel
- AN
- Medical specialty
- Anesthesiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Definition
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Market data
- Cleared 510(k) submissions
- 6
- Registered establishments
- 2
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown