510(k) K034032
K034032 is an FDA 510(k) premarket notification submitted by Respironics California, Inc. for the device "PLV CONTINUUM VENTILATOR, MODEL P2000". The FDA issued a decision of Substantially Equivalent on March 16, 2004. The device falls under product code NOU (Continuous, Ventilator, Home Use), a Class II device regulated under 21 CFR 868.5895. Respironics California, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2004
- Date Received
- December 29, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Continuous, Ventilator, Home Use
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type
This product code was needed for the home use indication. CBK is not a tracked device and NOU is a tracked device.