The following data is part of a premarket notification filed by Medlog Gmbh Marketing Services with the FDA for Use 77 Ultrasonic Nebulizer.
Device ID | K832086 |
510k Number | K832086 |
Device Name: | USE 77 ULTRASONIC NEBULIZER |
Classification | Nebulizer (direct Patient Interface) |
Applicant | MEDLOG GMBH MARKETING SERVICES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-06-28 |
Decision Date | 1983-07-19 |