The following data is part of a premarket notification filed by Ino Therapeutics with the FDA for Inomax Dsir (delivery System).
Device ID | K130605 |
510k Number | K130605 |
Device Name: | INOMAX DSIR (DELIVERY SYSTEM) |
Classification | Apparatus, Nitric Oxide Delivery |
Applicant | INO THERAPEUTICS 2902 DAIRY DRIVE Madison, WI 53718 |
Contact | Robert Bovy |
Correspondent | Robert Bovy INO THERAPEUTICS 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-03-07 |
Decision Date | 2013-05-02 |
Summary: | summary |