510(k) K924167

CRIT-LINE by Noninvasive Medical Technology Corp. — Product Code JPI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1993
Date Received
August 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Hematocrit Measuring
Device Class
Class II
Regulation Number
864.6400
Review Panel
HE
Submission Type