FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
The NOxBOXi Nitric Oxide Delivery System
K Number: K201339
·
Decision Jun 19, 2020
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
32
Applicant Total
2
Review Days
30
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Basic Information
- Device Name
- The NOxBOXi Nitric Oxide Delivery System
- K Number
- K201339
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5165
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Praxair, Inc.
- Date Received
- May 20, 2020
- Decision Date
- June 19, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRN), ordered by most recent decision date.
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Evolve Nitric Oxide Delivery System
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NOxBOXi Nitric Oxide Delivery System
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Praxair, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K051192 | PRAXAIR MEDICAL AIR MIXER | Sep 6, 2005 | Substantially Equivalent |