NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER— 510(k) K990897
Substantially EquivalentPuritan-Bennett Ireland, Ltd.
FDA 510(k) clearance K990897 for NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER, Substantially Equivalent on 2000-03-15. Applicant: Puritan-Bennett Ireland, Ltd.. Device class: 2.
Clearance details
- Applicant
- Puritan-Bennett Ireland, Ltd.
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Galway, IE
Recent devices under product code CAF
view allAdverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
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 K990897
K-number listed on FDA's recall record- Z-0821-2014 — Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
- Z-0822-2014 — Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990897.
Data sourced from openFDA. This site is unofficial and independent of the FDA.