MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER— 510(k) K033613
Substantially EquivalentBiotronik, Inc.
FDA 510(k) clearance K033613 for MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER, Substantially Equivalent on 2003-12-08. Applicant: Biotronik, Inc..
Clearance details
- Applicant
- Biotronik, Inc.
- Product code
- Code DTA
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lake Oswego, OR, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.