510(k) K823246

AUSTIN INHALATOR by Ems Industries, Inc. — Product Code BYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1982
Date Received
November 1, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Pressure And Accessories
Device Class
Class I
Regulation Number
868.5860
Review Panel
AN
Submission Type