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Phlebograph, Impedance

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2750
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.2750 Impedance phlebograph

§ 870.2750 Impedance phlebograph.

(a) Identification. An impedance phlebograph is a device used to provide a visual display of the venous pulse or drainage by measuring electrical impedance changes in a region of the body.

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

Phlebograph, Impedance

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.2750
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 870.2750 Impedance phlebograph

§ 870.2750 Impedance phlebograph.

(a) Identification. An impedance phlebograph is a device used to provide a visual display of the venous pulse or drainage by measuring electrical impedance changes in a region of the body.

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