Digital Ballistocardiograph, Model DGB 300
FDA 510(k) K081603 · Heartforce Medical, Inc.
510(k) numberK081603
Submission
- Device name
- Digital Ballistocardiograph, Model DGB 300
- Applicant
- Heartforce Medical, Inc.
Appollo Beach, FL, US - Received
- June 6, 2008
- Decision date
- July 24, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXR – Ballistocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2320
- Specialty
- Cardiovascular
Other 510(k)s with product code DXR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243566 | CardioTagDXR · Traditional | Cardiosense, Inc. | 07/22/2025SE |
| K160656 | CorSensDXR · Traditional | Corsens Medical , Ltd. | 11/21/2016SE |
| K870442 | QuantascopeDXR · Traditional | Vital Science Corp. | 08/11/1987SN |
| K863508 | Frantz Medical ElectrodeDXR · Traditional | Frantz Medical Development, Ltd. | 02/06/1987SE |
Questions and answers
When was Digital Ballistocardiograph, Model DGB 300 cleared by the FDA?
Digital Ballistocardiograph, Model DGB 300 (K081603) received a 510(k) decision of Substantially Equivalent on July 24, 2009, 413 days after the submission was received.
What is the product code of K081603?
The FDA product code is DXR – Ballistocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2320.