DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
FDA 510(k) clearance K081603 · decided 2009-07-24
Clearance details
- K-number
- K081603
- Device name
- DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
- Applicant
- Heartforce Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-06-06
- Decision date
- 2009-07-24
- Days to decision
- 413 days
- Clearance type
- Traditional
- Product code
- DXR
- Device class
- 2
- Regulation number
- 870.2320
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Appollo Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.