← FDA Medical Device Classifications

Stimulator, Caloric-Air

KHH · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.1800

Classification

FDA Product Code
KHH
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 874.1800
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
7
Registered establishments
12

Source

Authoritative
FDA Device Classification database
Machine
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