Product code NZH— General Hospital
EMMA
- Classification name
- Medication Management System, Remote
- Device class
- Class 2
- Regulation
- 21 CFR 880.6315
- Advisory panel
- General Hospital
- Total cleared
- 2
- First cleared
- Most recent
FDA classification definition
“A remote medication management system provides a means for the patient's prescribed medications to be stored in a delivery unit; For a medical provider to remotely schedule the patient's prescribed medications; To provide notification to the patient when the prescribed medications are due to be taken; To release the prescribed medications to a tray of the delivery unit accessible to the patient on the patient's command; And to provide to the medical provider a history of the event. The system is intended for use as an aid to medical providers in managing therapeutic regimens for patients in the home or clinic.”
Market context for product code NZH
FDA has cleared devices under product code NZH between 2007 and 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2015
- 2007
Top applicants under product code NZH
Adverse events under product code NZH
product code NZH- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NZH
Data sourced from openFDA. This site is unofficial and independent of the FDA.