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Preamplifier, Ac-Powered, Ophthalmic

HLT · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1640

Classification

FDA Product Code

HLT

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 886.1640

Review panel

OP

Medical specialty

Ophthalmic

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

4

Registered establishments

2

Source

Authoritative

FDA Device Classification database

Machine

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