510(k) K023414
- Device
- MIDA ALGORITHM REV. B
- Applicant
- Ortivus AB
- 510(k) number
- K023414
- Product code
- DYC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-12-05
- Date received
- 2002-10-11
- Regulation
- 870.2400
- Classification name
- Vectorcardiograph
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- KENNETH EKLUND
- Address
- Enhagsslingan 5 Taby SE SE-18325 SE-18325
FDA Registration Numbers#
- 3004215117
- 1412854
- 3003971136