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.. Device class: 2.
Clearance details
- Applicant
- Biotronik, Inc.
- Product code
- Code DTA
- Device class
- Class 2
- Regulation
- 21 CFR 870.3720
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lake Oswego, OR, US
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More clearances from Biotronik, Inc.
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