AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
FDA 510(k) clearance K023099 · decided 2002-10-18
Clearance details
- K-number
- K023099
- Device name
- AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-18
- Decision date
- 2002-10-18
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DTB
- Device class
- 3
- Regulation number
- 870.3680
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.