Product Code: DQB FDA class 2 21 CFR 870.2750

Phlebograph, Impedance

Cardiovascular

The Impedance Phlebograph is a cardiovascular diagnostic device used to measure blood flow and detect venous thrombosis by passing a small electrical current through tissue and measuring changes in impedance. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQB and it is regulated under 21 CFR 870.2750 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
7

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Basic Information

Product Code
DQB
Device Class
FDA class 2
Regulation Number
870.2750
Medical Specialty
Cardiovascular
Review Panel
CV
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 3 510(k) clearances via K numbers.

K Number Device Name
K851102 VASOSCREEN IMPEDANCE PLETHYSMOGRAPH
K822873 DEVETHERM
K772093 IMPEDANCE RHEOGRAPH