O-TWO E700,O-TWO E600,O-TWO E500
FDA 510(k) clearance K141595 · decided 2015-03-16
Clearance details
- K-number
- K141595
- Device name
- O-TWO E700,O-TWO E600,O-TWO E500
- Applicant
- O-Two Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-06-13
- Decision date
- 2015-03-16
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- BTL
- Device class
- 2
- Regulation number
- 868.5925
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mississauga, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| e500 Automatic Transport Ventilator, Model Number 01EVE500 recall (Z-0976-2019) | O-Two Medical Technologies, Inc. | 2019-04-04 |
| e600 Automatic Transport Ventilator, Model Number 01EVE600 recall (Z-0977-2019) | O-Two Medical Technologies, Inc. | 2019-04-04 |
| e700 Automatic Transport Ventilator, Model Number 01EVE700 recall (Z-0978-2019) | O-Two Medical Technologies, Inc. | 2019-04-04 |