ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000— 510(k) K041412
Substantially EquivalentRespironics California, Inc.
FDA 510(k) clearance K041412 for ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000, Substantially Equivalent on 2004-06-18. Applicant: Respironics California, Inc.. Device class: 2.
Clearance details
- Applicant
- Respironics California, 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
- Special
- Location
- Carlsbad, CA, US
Recent devices under product code CBK
view allMore clearances from Respironics California, 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 K041412
K-number listed on FDA's recall record- Z-0485-2015 — Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients.
- Z-2084-2013 — Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K041412.
Data sourced from openFDA. This site is unofficial and independent of the FDA.