510(k) K771550

MRT DISPENSOR by Mcgaw Respiratory Therapy — Product Code CAF

K771550 is an FDA 510(k) premarket notification submitted by Mcgaw Respiratory Therapy for the device "MRT DISPENSOR". The FDA issued a decision of Substantially Equivalent on September 20, 1977. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Mcgaw Respiratory Therapy has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1977
Date Received
August 12, 1977
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