The following data is part of a premarket notification filed by Ino Therapeutics with the FDA for Inomax Ds (delivery System), Model 10003.
Device ID | K080484 |
510k Number | K080484 |
Device Name: | INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
Classification | Apparatus, Nitric Oxide Delivery |
Applicant | INO THERAPEUTICS 6 ROUTE 173 Clinton, NJ 08809 |
Contact | David Trueblood |
Correspondent | David Trueblood INO THERAPEUTICS 6 ROUTE 173 Clinton, NJ 08809 |
Product Code | MRN |
Subsequent Product Code | MRO |
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 | 2008-02-22 |
Decision Date | 2008-08-06 |
Summary: | summary |