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Transducer, Vessel Occlusion

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2890
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.2890 Vessel occlusion transducer

§ 870.2890 Vessel occlusion transducer.

(a) Identification. A vessel occlusion transducer is a device used to provide an electrical signal corresponding to sounds produced in a partially occluded vessel. This device includes motion, sound, and ultrasonic transducers.

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

Transducer, Vessel Occlusion

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2890
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.2890 Vessel occlusion transducer

§ 870.2890 Vessel occlusion transducer.

(a) Identification. A vessel occlusion transducer is a device used to provide an electrical signal corresponding to sounds produced in a partially occluded vessel. This device includes motion, sound, and ultrasonic transducers.

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