ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
FDA 510(k) clearance K023350 · decided 2002-11-06
Clearance details
- K-number
- K023350
- Device name
- ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
- Applicant
- Respironics California, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-07
- Decision date
- 2002-11-06
- Days to decision
- 30 days
- Clearance type
- Traditional
- 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
+ Add to Predicate Builder ◉ Watch Respironics California
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |
| Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power recall (Z-0008-2015) | Respironics California Inc | 2014-10-21 |
| Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000 recall (Z-2084-2013) | Respironics California Inc | 2013-08-26 |
| 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 |
| Esprit Ventilator recall (Z-1230-04) | Respironics California Inc | 2004-07-28 |