510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NZHClass II

Medication Management System, Remote

21 CFR 880.6315 / General Hospital
FDA source (opens on fda.gov)

NZH is the FDA product code for Medication Management System, Remote, a class II device type, regulated under 21 CFR 880.6315. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NZH
Device name
Medication Management System, Remote
FDA 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.
Regulation
21 CFR 880.6315
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NZH

By decision year
2 clearances under product code NZH with a decision year between 2007 and 2015, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NZH by decision year
YearClearances
20071
20151

Applicants with the most clearances

Product code NZH
Applicants holding the most 510(k) clearances under product code NZH
ApplicantClearances
Inrange Systems, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NZH.