510(k) K902627

INTERFLO MEDICAL MODEL OXI/CO FILA. THERMO. CATH. by Biometric Research Institute, Inc. — Product Code KRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1991
Date Received
June 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Thermodilution
Device Class
Class II
Regulation Number
870.1915
Review Panel
CV
Submission Type