ESPIRT— 510(k) K001208
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K001208 for ESPIRT, Substantially Equivalent on 2000-05-12. Applicant: Respironics, Inc.. Device class: 2.
Clearance details
- Applicant
- Respironics, 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
- Pittsburgh, PA, US
Recent devices under product code CBK
view allMore clearances from Respironics, 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 K001208
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-0008-2015 — Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
- 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 K001208.
Data sourced from openFDA. This site is unofficial and independent of the FDA.