510(k) K002598

EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING by J. H. Emerson Co. — Product Code NHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2000
Date Received
August 21, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type