The following data is part of a premarket notification filed by Ino Therapeutics with the FDA for Ino Therapeutics Inomax Ds (delivery System), Model 10003.
Device ID | K061901 |
510k Number | K061901 |
Device Name: | INO THERAPEUTICS INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
Classification | Apparatus, Nitric Oxide Delivery |
Applicant | INO THERAPEUTICS 7601-B MURPHY DRIVE Middleton, WI 53562 |
Contact | Frederick Montgomery |
Correspondent | Frederick Montgomery INO THERAPEUTICS 7601-B MURPHY DRIVE Middleton, WI 53562 |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-05 |
Decision Date | 2006-12-14 |
Summary: | summary |