FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
CROSSVENT-4 VENTILATOR
K Number: K942938
·
Decision Sep 19, 1995
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
504
Applicant Total
14
Review Days
454
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Basic Information
- Device Name
- CROSSVENT-4 VENTILATOR
- K Number
- K942938
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Bio-Med Devices, Inc.
- Date Received
- June 22, 1994
- Decision Date
- September 19, 1995
- 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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|---|---|---|---|
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| K896381 | MVP-10 MRI INFANT VENTILATOR | Feb 12, 1990 | Substantially Equivalent |
| K896380 | IC-2A MRI ADULT/PEDIATRIC VENTILATOR | Feb 12, 1990 | Substantially Equivalent |
| K873614 | CBG CUFF MANOMETER | Jan 22, 1988 | Substantially Equivalent |
| K871337 | M-2 OXYGEN/TEMPERATURE MONITOR | Jun 5, 1987 | Substantially Equivalent |
| K871336 | M-1 PRESSURE MONITOR | Jun 5, 1987 | Substantially Equivalent |
| K871139 | M-10 VENTILATION MONITOR | Apr 21, 1987 | Substantially Equivalent |
| K830230 | PROGRAMMABLE VENTILATOR | Feb 9, 1983 | Substantially Equivalent |
| K823861 | ET-3 EMERGENCY TRANSPORT VENTILATOR | Feb 7, 1983 | Substantially Equivalent |