510(k) K955018

TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR by Instrumentarium Corp. — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1996
Date Received
November 2, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ph, Stomach
Device Class
Class I
Regulation Number
876.1400
Review Panel
GU
Submission Type