510(k) K871868

VENTI-SCAN II by Atomic Products Corp. — Product Code IYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1988
Date Received
May 13, 1987
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