510(k) K942593

OXYCHEK OXYGEN ANALYZER by Nidek Medical Products, Inc. — Product Code CCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1995
Date Received
June 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type