Phlebograph, Impedance
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.
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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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K851102 | VASOSCREEN IMPEDANCE PLETHYSMOGRAPH | May 16, 1985 | Substantially Equivalent | Sonicaid, Inc. |
| K822873 | DEVETHERM | Mar 24, 1983 | Substantially Equivalent | Eko Scann AB |
| K772093 | IMPEDANCE RHEOGRAPH | Nov 18, 1977 | Substantially Equivalent | Dynatech Research & Development Co. |