SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
FDA 510(k) clearance K980869 · decided 1998-09-10
Clearance details
- K-number
- K980869
- Device name
- SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-06
- Decision date
- 1998-09-10
- Days to decision
- 188 days
- Clearance type
- Traditional
- 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.