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Echoencephalograph

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1240
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1240 Echoencephalograph

§ 882.1240 Echoencephalograph.

(a) Identification. An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head.

(b) Classification. Class II (performance standards).

Echoencephalograph

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1240
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1240 Echoencephalograph

§ 882.1240 Echoencephalograph.

(a) Identification. An echoencephalograph is an ultrasonic scanning device (including A-scan, B-scan, and doppler systems) that uses noninvasive transducers for measuring intracranial interfaces and blood flow velocity to and in the head.

(b) Classification. Class II (performance standards).