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
KMGClass II

Purifier, Water, Ultraviolet, Medical

21 CFR 880.6710 / General Hospital
FDA source (opens on fda.gov)

KMG is the FDA product code for Purifier, Water, Ultraviolet, Medical, a class II device type, regulated under 21 CFR 880.6710. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KMG
Device name
Purifier, Water, Ultraviolet, Medical
Regulation
21 CFR 880.6710
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code KMG

By decision year
9 clearances under product code KMG with a decision year between 1981 and 2001, 1981 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code KMG by decision year
YearClearances
19816
19832
20011

Applicants with the most clearances

Product code KMG
Applicants holding the most 510(k) clearances under product code KMG
ApplicantClearances
Cooper-Hewitt Electric Co.6
Apollo Corp.1
Mallinckrodt Critical Care1
Sherwood Medical Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code