PALMTOP VENTILATOR, MODELS PTV-8, PTV-10— 510(k) K070594
Substantially EquivalentPulmonetic Systems, Inc.
FDA 510(k) clearance K070594 for PALMTOP VENTILATOR, MODELS PTV-8, PTV-10, Substantially Equivalent on 2007-08-01. Applicant: Pulmonetic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Pulmonetic Systems, Inc.
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code CBK
view allMore clearances from Pulmonetic Systems, Inc.
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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 K070594
K-number listed on FDA's recall record- Z-2593-2014 — CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
- Z-2006-2012 — CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070594.
Data sourced from openFDA. This site is unofficial and independent of the FDA.