510(k) K870442
- Device
- QUANTASCOPE
- Applicant
- VITAL SCIENCE CORP.
- 510(k) number
- K870442
- Product code
- DXR
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1987-08-11
- Date received
- 1987-02-03
- Regulation
- 870.2320
- Classification name
- Ballistocardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD J ZAHORIK
- Address
- Boettcher Bldg. Suite 625 8400 E. Prentice Ave. Englewood CO US 80111 80111
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DXR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243566 | CardioTag™ | Cardiosense, Inc. | 2025-07-22 |
| K160656 | CorSens | Corsens Medical , Ltd. | 2016-11-21 |
| K081603 | DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300 | Heartforce Medical, Inc. | 2009-07-24 |
| K863508 | FRANTZ MEDICAL ELECTRODE | Frantz Medical Development, Ltd. | 1987-02-06 |
Legacy Summary#
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FDA Review#
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