FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
K Number: K052554
·
Decision Sep 23, 2005
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
6
Review Days
7
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Basic Information
- Device Name
- MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
- K Number
- K052554
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Versamed Medical Systems, Inc.
- Date Received
- September 16, 2005
- Decision Date
- September 23, 2005
- 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 Versamed Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081845 | IVENT101 | Mar 16, 2009 | Substantially Equivalent |
| K073694 | IVENT 2001 MRI CONDITIONAL | May 30, 2008 | Substantially Equivalent |
| K061627 | MODIFICATION TO I VENT 201 | Jun 29, 2006 | Substantially Equivalent |
| K053270 | IVENT 201 | Jan 27, 2006 | Substantially Equivalent |
| K042468 | IVENT 201 PORTABLE VENTILATOR | Nov 17, 2004 | Substantially Equivalent |