← FDA Medical Device Classifications
Cranial Sound Monitor
QBE · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1875
Classification
- FDA Product Code
QBE- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.1875
- Review panel
- NE
- Medical specialty
- Cardiovascular
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To non-invasively detect, monitor, record and display acoustic signals in the brain.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown