Product Code: DXR
FDA class 2
21 CFR 870.2320
Ballistocardiograph
Cardiovascular
The Ballistocardiograph is a cardiovascular diagnostic device that records the mechanical movements of the body resulting from cardiac ejection of blood with each heartbeat, used to assess cardiac function indirectly. It is classified as FDA Class 2, indicating moderate risk, and must receive 510(k) clearance before marketing. The product code is DXR and the applicable regulation is 21 CFR 870.2320, under the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
30
Basic Information
- Product Code
- DXR
- Device Class
- FDA class 2
- Regulation Number
- 870.2320
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K160656 | CorSens | Nov 21, 2016 | Substantially Equivalent | CorSens Medical Ltd. |
| K081603 | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 | Jul 24, 2009 | Substantially Equivalent | HEARTFORCE MEDICAL, INC. |
| K870442 | QUANTASCOPE | Aug 11, 1987 | Substantially Equivalent for Some Indications | VITAL SCIENCE CORP. |
| K863508 | FRANTZ MEDICAL ELECTRODE | Feb 06, 1987 | Substantially Equivalent | FRANTZ MEDICAL DEVELOPMENT, LTD. |