FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
VIANOX DELIVERY SYSTEM, MODEL II
K Number: K033779
·
Decision Jan 26, 2004
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
32
Applicant Total
2
Review Days
53
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Basic Information
- Device Name
- VIANOX DELIVERY SYSTEM, MODEL II
- K Number
- K033779
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5165
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulmonox Medical, Inc.
- Date Received
- December 4, 2003
- Decision Date
- January 26, 2004
- Product Code
- MRN
- 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 |
|---|---|---|---|
| MRN | Apparatus, Nitric Oxide Delivery | FDA class 2 | Anesthesiology |
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Other Clearances by Pulmonox Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023014 | VIANOX DELIVERY SYSTEM, MODEL I | Aug 14, 2003 | Substantially Equivalent |