FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INOMAX DS (DELIVERY SYSTEM)
K Number: K121021
·
Decision Sep 24, 2012
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
32
Applicant Total
8
Review Days
173
Basic Information
- Device Name
- INOMAX DS (DELIVERY SYSTEM)
- K Number
- K121021
- 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
- Date Received
- April 4, 2012
- Decision Date
- September 24, 2012
- 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
| K Number | Device Name | ||
|---|---|---|---|
| K130605 | INOMAX DSIR (DELIVERY SYSTEM) | May 2, 2013 | Substantially Equivalent |
| K122689 | INOBLENDER | Nov 7, 2012 | Substantially Equivalent |
| K110344 | INOMAX DSIR (DELIVERY SYSTEM) | Jun 24, 2011 | Substantially Equivalent |
| K093922 | INOMAX DS | Apr 15, 2010 | Substantially Equivalent |
| K080484 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Aug 6, 2008 | Substantially Equivalent |
| K061901 | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Dec 14, 2006 | Substantially Equivalent |
| K052663 | INO THERAPEUTICS INOBLENDER, MODEL 10004 | Nov 4, 2005 | Substantially Equivalent |