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510(k) K902366

MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT by Synectics-Dantec — Product Code FFT

K902366 is an FDA 510(k) premarket notification submitted by Synectics-Dantec for the device "MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT". The FDA issued a decision of Substantially Equivalent on June 8, 1990. The device falls under product code FFT (Electrode, Ph, Stomach), a Class I device regulated under 21 CFR 876.1400. Synectics-Dantec has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1990
Date Received
May 16, 1990
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

Other clearances by Synectics-Dantec

  • K961346 — PH ANALYSIS MODULE (January 29, 1997)
  • K925405 — ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF. (September 30, 1994)
  • K924875 — MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS (June 30, 1994)
  • 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)

Other clearances for product code FFT

  • K102543 — BRAVO PH MONITORING SYSTEM AND ACCESSORIES (December 1, 2010)
  • K013951 — SANDHILL SCIENTIFIC PEDIATEC PH PROBE (February 28, 2002)
  • K002028 — BRAVO PH MONITORING SYSTEM (September 29, 2000)
  • 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)

FDA data resources