PACEMAKER SYS ANALYZER #384— 510(k) K833647
Substantially EquivalentPacesetter Systems
FDA 510(k) clearance K833647 for PACEMAKER SYS ANALYZER #384, Substantially Equivalent on 1983-12-16. Applicant: Pacesetter Systems. Device class: 2.
Clearance details
- Applicant
- Pacesetter Systems
- 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
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