510(k) K832086

USE 77 ULTRASONIC NEBULIZER by Medlog GmbH Marketing Services — Product Code CAF

K832086 is an FDA 510(k) premarket notification submitted by Medlog GmbH Marketing Services for the device "USE 77 ULTRASONIC NEBULIZER". The FDA issued a decision of Substantially Equivalent on July 19, 1983. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Medlog GmbH Marketing Services has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1983
Date Received
June 28, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type