LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
FDA 510(k) clearance K093832 · decided 2010-01-13
Clearance details
- K-number
- K093832
- Device name
- LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES
- Applicant
- Levitronix, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-12-14
- Decision date
- 2010-01-13
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DWA
- Device class
- 2
- Regulation number
- 870.4380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.