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

Disinfector, Medical Devices

21 CFR 880.6992 / General Hospital
FDA source (opens on fda.gov)

MEC is the FDA product code for Disinfector, Medical Devices, a class II device type, regulated under 21 CFR 880.6992. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 31 recalls.

Classification record

Product code
MEC
Device name
Disinfector, Medical Devices
Regulation
21 CFR 880.6992
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
2
Ingested recalls
31

Clearances, product code MEC

By decision year
2 clearances under product code MEC with a decision year between 1994 and 2008, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MEC by decision year
YearClearances
19941
20081

Applicants with the most clearances

Product code MEC
Applicants holding the most 510(k) clearances under product code MEC
ApplicantClearances
Hamo USA, Inc.1
Olympic Medical Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order