FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLV CONTINUUM VENTILATOR, MODEL P2000
K Number: K034032
·
Decision Mar 16, 2004
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
6
Applicant Total
11
Review Days
78
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Basic Information
- Device Name
- PLV CONTINUUM VENTILATOR, MODEL P2000
- K Number
- K034032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics California, Inc.
- Date Received
- December 29, 2003
- Decision Date
- March 16, 2004
- Product Code
- NOU
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NOU | Continuous, Ventilator, Home Use | FDA class 2 | Anesthesiology |
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Other Clearances by Respironics California, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110083 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE | Jan 13, 2012 | Substantially Equivalent |
| K110795 | V200 INTELLI-TRAK OPTION | Aug 19, 2011 | Substantially Equivalent |
| K102054 | V200 VENTILATOR | Dec 22, 2010 | Substantially Equivalent |
| K082660 | V60 VENTILATOR, MODEL V8000 | Jan 9, 2009 | Substantially Equivalent |
| K072450 | ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 | Dec 12, 2007 | Substantially Equivalent |
| K071212 | ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 | Jul 30, 2007 | Substantially Equivalent |
| K051262 | ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 | Jul 8, 2005 | Substantially Equivalent |
| K041412 | ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 | Jun 18, 2004 | Substantially Equivalent |
| K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 | Nov 20, 2003 | Substantially Equivalent |
| K023350 | ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS | Nov 6, 2002 | Substantially Equivalent |