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510(k) K850361

SYNECTICS PH SYS COMPRISING DIGITRAPPER MARK II, E by Synectics-Dantec — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1985
Date Received
January 30, 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

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  • K914793 — MONOCRYSTANT PH/LES CATHETER, MODIFICATION (December 13, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K913817 — MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION (June 11, 1992)
  • K914624 — PH METER, MODIFICATION (April 28, 1992)
  • K914219 — AIRWAY THERMISTOR (February 26, 1992)
  • K913387 — DIGITRAPPER MARK III (December 27, 1991)
  • K904625 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM (August 20, 1991)

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  • K961346 — PH ANALYSIS MODULE (January 29, 1997)
  • K950087 — LOT 440 (February 6, 1996)
  • K955018 — TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (January 30, 1996)
  • K945069 — FLEXILOG 2000 (June 13, 1995)
  • K920849 — TRIP CIC CATHETER (March 17, 1995)
  • K934434 — CYBERRX MODEL 7200 (January 24, 1995)
  • K925405 — ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (September 30, 1994)