O-TWO E700,O-TWO E600,O-TWO E500— 510(k) K141595
Substantially EquivalentO-Two Medical Technologies, Inc.
FDA 510(k) clearance K141595 for O-TWO E700,O-TWO E600,O-TWO E500, Substantially Equivalent on 2015-03-16. Applicant: O-Two Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- O-Two Medical Technologies, Inc.
- Product code
- Code BTL
- Device class
- Class 2
- Regulation
- 21 CFR 868.5925
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mississauga, CA
Recent devices under product code BTL
view allMore clearances from O-Two Medical Technologies, Inc.
view allAdverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K141595
K-number listed on FDA's recall record- Z-0976-2019 — e500 Automatic Transport Ventilator, Model Number 01EVE500
- Z-0977-2019 — e600 Automatic Transport Ventilator, Model Number 01EVE600
- Z-0978-2019 — e700 Automatic Transport Ventilator, Model Number 01EVE700
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141595.
Data sourced from openFDA. This site is unofficial and independent of the FDA.