PLV CONTINUUM VENTILATOR, MODEL P2000
FDA 510(k) clearance K034032 · decided 2004-03-16
Clearance details
- K-number
- K034032
- Device name
- PLV CONTINUUM VENTILATOR, MODEL P2000
- Applicant
- Respironics California, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-29
- Decision date
- 2004-03-16
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- NOU
- 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vivo 45 LS (K233452) | Breas Medical AB | 2025-01-13 |
| Vivo 45 LS (K193586) | Breas Medical AB | 2021-01-27 |
| Vivo 60 (K160481) | Breas Medical AB | 2016-11-09 |
| VIVO 50 (K123144) | Ge Healthcare, Breas Medical AB | 2013-06-18 |
| PLV CONTINUUM VENTILATOR, MODEL P1000 (K022750) | Respironics California, Inc. | 2003-11-20 |
| IVENT 201 PORTABLE VENTILATOR (K021981) | Versamed , Ltd. | 2003-08-13 |
Recalls involving this device
No recalls on record reference this clearance.