510(k) K081603
K081603 is an FDA 510(k) premarket notification submitted by Heartforce Medical, Inc. for the device "DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300". The FDA issued a decision of Substantially Equivalent on Jul 24, 2009. The device falls under product code DXR (Ballistocardiograph), a Class II device regulated under 21 CFR 870.2320.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2009
- Date Received
- Jun 6, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ballistocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2320
- Review Panel
- CV
- Submission Type