FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
K Number: K083693
·
Decision Apr 2, 2009
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
5
Review Days
111
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Basic Information
- Device Name
- PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
- K Number
- K083693
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien, Formerly Nellcor Puritan Bennett, Inc.
- Date Received
- December 12, 2008
- Decision Date
- April 2, 2009
- Product Code
- CBK
- 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 |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | FDA class 2 | Anesthesiology |
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Other Clearances by Covidien, Formerly Nellcor Puritan Bennett, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K123581 | NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN | May 9, 2013 | Substantially Equivalent |
| K123002 | VITAL SYNC SYSTEM | Feb 27, 2013 | Substantially Equivalent |
| K092847 | 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION | Mar 11, 2010 | Substantially Equivalent |
| K082966 | PB 540 VENTILATOR | Oct 31, 2008 | Substantially Equivalent |