TRILOGY 100 VENTILATOR
FDA 510(k) clearance K083526 · decided 2009-03-13
Clearance details
- K-number
- K083526
- Device name
- TRILOGY 100 VENTILATOR
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
- Decision
- Substantially Equivalent
- Date received
- 2008-11-28
- Decision date
- 2009-03-13
- Days to decision
- 105 days
- Clearance type
- Abbreviated
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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