FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BERNOULLI VENTILATOR MANAGEMENT SYSTEM
K Number: K011861
·
Decision Nov 6, 2001
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
13
Applicant Total
9
Review Days
145
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BERNOULLI VENTILATOR MANAGEMENT SYSTEM
- K Number
- K011861
- 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
- June 14, 2001
- Decision Date
- November 6, 2001
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOD), ordered by most recent decision date.
CorVision® (91-205-Z0014)
FDA 510(k)
FDA Class 2
·Anesthesiology
EveryWare
FDA 510(k)
FDA Class 2
·Anesthesiology
Care Cycle Connect Application
FDA 510(k)
FDA Class 2
·Anesthesiology
BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
FDA 510(k)
FDA Class 2
·Anesthesiology
VENTLINK SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
IISIS, VERSION 1.0
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| K020018 | MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE | Feb 21, 2002 | 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. |