FDA product code NZH: Medication Management System, Remote
NZH is the FDA product code for medication management system, remote. It is a Class II device, regulated under 21 CFR 880.6315 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under NZH. The average 510(k) review took 31 days (median 31). 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Medication Management System, Remote |
| Device class | Class II |
| Regulation | 21 CFR 880.6315 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NZH clearance
Top NZH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inrange Systems, Inc. | 1 | 2015-02-26 |
Most recent NZH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150174 | Inrange Systems, Inc. | EMMA | 2015-02-26 | 31 |
Recalls for NZH devices
openFDA lists no recalls for product code NZH.
Frequently asked questions
What is FDA product code NZH?
NZH is the FDA product code for medication management system, remote. It is a Class II device, regulated under 21 CFR 880.6315 and reviewed by the General Hospital panel.
What device class is NZH?
Class II, regulation 21 CFR 880.6315. Typical premarket route: 510(k).
How long does a 510(k) take for product code NZH?
Across 1 cleared submissions the average was 31 days from receipt to decision (median 31).
Which companies have the most NZH clearances?
Inrange Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NZH
- Run a recall and safety report across every NZH manufacturer
- Watch product code NZH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times