510(k) K100528
K100528 is an FDA 510(k) premarket notification submitted by Breathe Technologies, Inc. for the device "BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S". The FDA issued a decision of Substantially Equivalent on April 23, 2010. The device falls under product code ONZ (Mechanical Ventilator), a Class II device regulated under 21 CFR 868.5895. Breathe Technologies, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 2010
- Date Received
- February 24, 2010
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mechanical Ventilator
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type
This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,