INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
FDA 510(k) clearance K061901 · decided 2006-12-14
Clearance details
- K-number
- K061901
- Device name
- INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003
- Applicant
- Ino Therapeutics
- Decision
- Substantially Equivalent
- Date received
- 2006-07-05
- Decision date
- 2006-12-14
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- MRN
- Device class
- 2
- Regulation number
- 868.5165
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Middleton, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas i recall (Z-1745-2022) | Mallinckrodt, LLC. | 2022-09-13 |
| INOmax DS (Delivery System) Model 10003 & 10007. The INOMAX DS Delivery System delivers IN recall (Z-0583-2012) | Ino Therapeutics | 2012-01-11 |
| Ikaria INOMAX DS Drug Delivery System, model 10003. Ikaria 6 Route 173, Clinton, NJ 08809 recall (Z-2176-2010) | Ikaria Holdings | 2010-08-13 |