FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
IVENT 201 PORTABLE VENTILATOR
K Number: K021981
·
Decision Aug 13, 2003
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
6
Applicant Total
3
Review Days
422
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Basic Information
- Device Name
- IVENT 201 PORTABLE VENTILATOR
- K Number
- K021981
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Versamed , Ltd.
- Date Received
- June 17, 2002
- Decision Date
- August 13, 2003
- Product Code
- NOU
- 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 |
|---|---|---|---|
| NOU | Continuous, Ventilator, Home Use | FDA class 2 | Anesthesiology |
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