Product Code: QAF
FDA class 2
21 CFR 870.2770
Impedance Plethysmograph, Cranial
Cardiovascular
The Impedance Plethysmograph, Cranial is a non-invasive cardiovascular/neurological device intended to detect or measure variations in cranial volume by using tissue impedance properties, used to assess intracranial hemodynamics. It is classified as a Class 2 device under regulation 870.2770, requiring 510(k) premarket notification, falling within the Cardiovascular (CV) medical specialty with Neurology (NE) review. The product code is QAF. It is not an implant and is not life-sustaining.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
1
Basic Information
- Product Code
- QAF
- Device Class
- FDA class 2
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Definition
Detect or measure variations in volume in the cranium, using tissue impedance properties.
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.