The following data is part of a premarket notification filed by Ino Therapeutics Llc with the FDA for Inomax Ds (delivery System).
Device ID | K090958 |
510k Number | K090958 |
Device Name: | INOMAX DS (DELIVERY SYSTEM) |
Classification | Ventilatory Effort Recorder |
Applicant | INO THERAPEUTICS LLC 2902 DAIRY DR. Madison, WI 53718 |
Contact | David Trueblood |
Correspondent | David Trueblood INO THERAPEUTICS LLC 2902 DAIRY DR. Madison, WI 53718 |
Product Code | MNR |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-06 |
Decision Date | 2009-06-18 |
Summary: | summary |