Breathe Technologies Life2000™ Ventilation System
FDA 510(k) clearance K170037 · decided 2017-08-11
Clearance details
- K-number
- K170037
- Device name
- Breathe Technologies Life2000™ Ventilation System
- Applicant
- Breathe Technologies
- Decision
- Substantially Equivalent
- Date received
- 2017-01-04
- Decision date
- 2017-08-11
- Days to decision
- 219 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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