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Monitor, Eye Movement, Diagnostic

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1510
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.1510 Eye movement monitor

§ 886.1510 Eye movement monitor.

(a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.

(b) Classification. Class II.

Monitor, Eye Movement, Diagnostic

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1510
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.1510 Eye movement monitor

§ 886.1510 Eye movement monitor.

(a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.

(b) Classification. Class II.