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510(k) K925405

ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. by Synectics-Dantec — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1994
Date Received
October 26, 1992
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

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  • K913817 — MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (June 11, 1992)
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  • K913387 — DIGITRAPPER MARK III (December 27, 1991)
  • K904625 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM (August 20, 1991)
  • K905520 — MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION (April 26, 1991)

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