ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
FDA 510(k) clearance K041412 · decided 2004-06-18
Clearance details
- K-number
- K041412
- Device name
- ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
- Applicant
- Respironics California, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-27
- Decision date
- 2004-06-18
- Days to decision
- 22 days
- Clearance type
- Special
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/ recall (Z-0485-2015) | Respironics California Inc | 2014-12-01 |
| Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000 recall (Z-2084-2013) | Respironics California Inc | 2013-08-26 |
| Respironics Esprit Ventilator System, Model Number V1000 with Optional External Battery; P recall (Z-1813-2009) | Respironics California Inc | 2009-08-11 |
| Esprit Ventilator, Model V1000 manufactured with Power Supply PN 1015852 The Esprit Ventil recall (Z-2002-2008) | Respironics California Inc | 2008-09-17 |
| Esprit Power Supply Snubber Board Assembly FRU, PN 1036236 The Esprit Ventilator is a micr recall (Z-2003-2008) | Respironics California Inc | 2008-09-17 |
| Esprit Power Supply Field Replacement Unit (FRU), PN 101 8246 The Esprit Ventilator is a m recall (Z-2004-2008) | Respironics California Inc | 2008-09-17 |