BIOTRONIK DNP UNIPOLAR— 510(k) K841450
Substantially EquivalentBiotronik Sales, Inc.
FDA 510(k) clearance K841450 for BIOTRONIK DNP UNIPOLAR, Substantially Equivalent on 1985-02-07. Applicant: Biotronik Sales, Inc.. Device class: 2.
Clearance details
- Applicant
- Biotronik Sales, Inc.
- 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
- Mchenry, IL, US
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