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

Decontamination Systems For N95 Respirators

Unknown
FDA source (opens on fda.gov)

QKY is the FDA product code for Decontamination Systems For N95 Respirators. FDA's definition for this code reads: "Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
QKY
Device name
Decontamination Systems For N95 Respirators
FDA definition
Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.
Device class
Not classified
Review panel
Unknown
Submission type
FDA code 8
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code