510(k) K170037
K170037 is an FDA 510(k) premarket notification submitted by Breathe Technologies for the device "Breathe Technologies Life2000 Ventilation System". The FDA issued a decision of Substantially Equivalent on Aug 11, 2017. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Breathe Technologies has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 11, 2017
- Date Received
- Jan 4, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Continuous, Facility Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type
- 510(k)