The following data is part of a premarket notification filed by Ino Therapeutics/ikaria with the FDA for Inomax Dsir (delivery System).
| Device ID | K131686 |
| 510k Number | K131686 |
| Device Name: | INOMAX DSIR (DELIVERY SYSTEM) |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | INO THERAPEUTICS/IKARIA 2902 DAIRY DRIVE Madison, WI 53718 |
| Contact | Robert Bovy |
| Correspondent | Robert Bovy INO THERAPEUTICS/IKARIA 2902 DAIRY DRIVE Madison, WI 53718 |
| Product Code | MRN |
| Subsequent Product Code | MRP |
| Subsequent Product Code | MRQ |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-10 |
| Decision Date | 2013-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867538000106 | K131686 | 000 |
| 00810055280254 | K131686 | 000 |
| 00810055285105 | K131686 | 000 |
| 00810055285099 | K131686 | 000 |
| 00810055285082 | K131686 | 000 |
| 00810055285075 | K131686 | 000 |
| 00810055285068 | K131686 | 000 |
| 00810055285051 | K131686 | 000 |
| 00810055285044 | K131686 | 000 |
| 00810055285037 | K131686 | 000 |
| 00810055285020 | K131686 | 000 |
| 00810055285013 | K131686 | 000 |
| 10810055280268 | K131686 | 000 |
| 00810055280278 | K131686 | 000 |
| 10810055284280 | K131686 | 000 |
| 10810055284150 | K131686 | 000 |
| 10810055284037 | K131686 | 000 |
| 10810055284020 | K131686 | 000 |
| 10810055283528 | K131686 | 000 |
| 10810055283481 | K131686 | 000 |
| 10810055283474 | K131686 | 000 |
| 10810055283443 | K131686 | 000 |
| 10810055280886 | K131686 | 000 |
| 10810055280299 | K131686 | 000 |
| 00810055280285 | K131686 | 000 |
| 00810055285006 | K131686 | 000 |