510(k) K952725

MULTICHECK by Radiometer America, Inc. — Product Code GLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1996
Date Received
June 14, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter To Measure Hemoglobin
Device Class
Class II
Regulation Number
864.7500
Review Panel
HE
Submission Type