← FDA Medical Device Classifications
Hemodialysis System For Home Use
ONW · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5860
Classification
- FDA Product Code
ONW- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 876.5860
- Review panel
- GU
- Medical specialty
- Gastroenterology, Urology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To treat and provide hemodialysis therapy at home for chronic renal failure patients.
Market data
- Cleared 510(k) submissions
- 4
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown