510(k) K970388— A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE
Substantially Equivalent - Subject to Tracking & PMSBiotronik, Inc.
Clearance details
- Applicant
- Biotronik, Inc.
- Product code
- Code DTD
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking & PMS
- Clearance type
- Traditional
- Location
- Lake Oswego, OR, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.