FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
K Number: K020018
·
Decision Feb 21, 2002
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
9
Review Days
49
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Basic Information
- Device Name
- MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE
- K Number
- K020018
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardiopulmonary Corp.
- Date Received
- January 3, 2002
- Decision Date
- February 21, 2002
- Product Code
- MSX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiopulmonary Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K130208 | BERNOULLI ENTERPRISE SOFTWARE | Dec 20, 2013 | Substantially Equivalent |
| K091461 | BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE | Aug 14, 2009 | 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 |
| 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. |