HEARTRAK SMART ECAT— 510(k) K083535
Substantially EquivalentUniversal Medical, Inc.
FDA 510(k) clearance K083535 for HEARTRAK SMART ECAT, Substantially Equivalent on 2008-12-15. Applicant: Universal Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Universal Medical, Inc.
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ewing, NJ, US
Recent devices under product code DXH
view allMore clearances from Universal Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.