FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
K Number: K091461
·
Decision Aug 14, 2009
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
13
Applicant Total
9
Review Days
88
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Basic Information
- Device Name
- BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
- K Number
- K091461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardiopulmonary Corp.
- Date Received
- May 18, 2009
- Decision Date
- August 14, 2009
- Product Code
- MOD
- 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 |
|---|---|---|---|
| MOD | Accessory To Continuous Ventilator (Respirator) | FDA class 2 | Anesthesiology |
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Other Clearances by Cardiopulmonary Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130208 | BERNOULLI ENTERPRISE SOFTWARE | Dec 20, 2013 | Substantially Equivalent |
| K061932 | BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE | Sep 14, 2006 | Substantially Equivalent |
| K051283 | MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE | Jun 23, 2005 | Substantially Equivalent |
| K020018 | MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE | Feb 21, 2002 | Substantially Equivalent |
| K011861 | BERNOULLI VENTILATOR MANAGEMENT SYSTEM | Nov 6, 2001 | Substantially Equivalent |
| K990429 | MODIFICATION OF VENTURI VENTILATOR | Feb 24, 1999 | Substantially Equivalent - Subject to Tracking Reg. |
| K982174 | VENTURI VENTILATOR | Jun 24, 1998 | Substantially Equivalent - Subject to Tracking Reg. |
| K943412 | VENTURI VENTILATOR | Oct 16, 1995 | Substantially Equivalent - Subject to Tracking Reg. |