FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INOMAX DS (DELIVERY SYSTEM)
K Number: K090958
·
Decision Jun 18, 2009
Classifications
1
FEI Numbers
84
Registration Numbers
84
Same Product Code
160
Applicant Total
5
Review Days
73
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Basic Information
- Device Name
- INOMAX DS (DELIVERY SYSTEM)
- K Number
- K090958
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ino Therapeutics, LLC
- Date Received
- April 6, 2009
- Decision Date
- June 18, 2009
- Product Code
- MNR
- 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 |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | FDA class 2 | Anesthesiology |
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Other Clearances by Ino Therapeutics, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K092545 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Mar 10, 2010 | Substantially Equivalent |
| K081691 | INOMAX DS (DELIVERY SYSTEM) | Aug 28, 2008 | Substantially Equivalent |
| K071516 | INOMAX DS | Oct 3, 2007 | Substantially Equivalent |
| K070867 | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 | Apr 27, 2007 | Substantially Equivalent |