510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NIHClass II

Disinfectant, Subsystem, Water Purification

21 CFR 876.5665 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NIH is the FDA product code for Disinfectant, Subsystem, Water Purification, a class II device type, regulated under 21 CFR 876.5665. FDA's definition for this code reads: "Disinfectant intended for reprocessing water purification systems for hemodialysis". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NIH
Device name
Disinfectant, Subsystem, Water Purification
FDA definition
Disinfectant intended for reprocessing water purification systems for hemodialysis.
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code NIH

By decision year
1 clearance under product code NIH with a decision year between 2014 and 2014, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NIH by decision year
YearClearances
20141

Applicants with the most clearances

Product code NIH
Applicants holding the most 510(k) clearances under product code NIH
ApplicantClearances
Medivators Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code