PACEMAKER SYS. ANALYZER 378— 510(k) K832959
Substantially EquivalentSiemens Elema AB
FDA 510(k) clearance K832959 for PACEMAKER SYS. ANALYZER 378, Substantially Equivalent on 1983-11-14. Applicant: Siemens Elema AB. Device class: 2.
Clearance details
- Applicant
- Siemens Elema AB
- Product code
- Code KRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.3640
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code KRE
view allMore clearances from Siemens Elema AB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.