FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INOMAX DSIR (DELIVERY SYSTEM)
K Number: K131686
·
Decision Nov 29, 2013
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
32
Applicant Total
2
Review Days
172
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Basic Information
- Device Name
- INOMAX DSIR (DELIVERY SYSTEM)
- K Number
- K131686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5165
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ino Therapeutics/Ikaria
- Date Received
- June 10, 2013
- Decision Date
- November 29, 2013
- 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 Ino Therapeutics/Ikaria
| K Number | Device Name | ||
|---|---|---|---|
| K143213 | INOmax DSIR Plus MRI | Jul 10, 2015 | Substantially Equivalent |