← FDA Medical Device Classifications
Pump, Infusion, Insulin Bolus
OPP · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5725
Classification
- FDA Product Code
OPP- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 880.5725
- Review panel
- CH
- Medical specialty
- General Hospital
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.
Market data
- Cleared 510(k) submissions
- 7
- Registered establishments
- 6
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown