← FDA Medical Device Classifications
Lung Sound Monitor
OCR · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1875
Classification
- FDA Product Code
OCR- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.1875
- Review panel
- AN
- Medical specialty
- Cardiovascular
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
The lung sound monitor is intended for use in monitoring and recording lung sounds.
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown