A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.— 510(k) K902889
Substantially EquivalentBiotronik, GmbH & Co.
FDA 510(k) clearance K902889 for A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE., Substantially Equivalent on 1990-08-23. Applicant: Biotronik, GmbH & Co.. Device class: 2.
Clearance details
- Applicant
- Biotronik, GmbH & Co.
- Product code
- Code DTD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3620
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Oswego, OR, US
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