MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS— 510(k) K073230
Substantially EquivalentBiotronik, Inc.
FDA 510(k) clearance K073230 for MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS, Substantially Equivalent on 2007-12-20. 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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