Sapphire NC Plus
FDA 510(k) clearance K162209 · decided 2016-10-06
Clearance details
- K-number
- K162209
- Device name
- Sapphire NC Plus
- Applicant
- Orbusneich Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-08-05
- Decision date
- 2016-10-06
- Days to decision
- 62 days
- Clearance type
- Special
- Product code
- LOX
- Device class
- 2
- Regulation number
- 870.5100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.