510(k) K896476

DISP. RADIOAEROSOL KIT (MP-400-M) TO FIT SHIELD by Medipart Jerry Alexander — Product Code IYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1990
Date Received
November 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Rebreathing, Radionuclide
Device Class
Class II
Regulation Number
892.1390
Review Panel
RA
Submission Type