← FDA Medical Device Classifications

Stand, Instrument, Ophthalmic, Battery Powered

NOI · Class I — Low Risk (general controls) · Ophthalmic · 21 CFR 886.1860

Classification

FDA Product Code
NOI
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 886.1860
Review panel
OP
Medical specialty
Ophthalmic
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N

Definition

AC-powered or non-powered device intended to store ophthalmic instruments in a readily accessible position.

Market data

Cleared 510(k) submissions
0
Registered establishments
9

Source

Authoritative
FDA Device Classification database
Machine
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