← FDA Medical Device Classifications

Accessories To Examination Light

PEQ · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6320

Classification

FDA Product Code
PEQ
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.6320
Review panel
HO
Medical specialty
General Hospital
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed.

Market data

Cleared 510(k) submissions
1
Registered establishments
8

Source

Authoritative
FDA Device Classification database
Machine
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