← FDA Medical Device Classifications

Bur, Ear, Nose And Throat

EQJ · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.4140

Classification

FDA Product Code
EQJ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 874.4140
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
18
Registered establishments
87

Source

Authoritative
FDA Device Classification database
Machine
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