510(k) K852289

MODEL SA3 ESOPHAGEAL PH ELECTRODE by World Precision Instruments, Inc. — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1985
Date Received
May 29, 1985
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