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510(k) K903646

GASTROGRAPH by Medics Instrument Corp. — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1990
Date Received
August 14, 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 Medics Instrument Corp.

  • K905154 — GASTROSCAN (June 19, 1991)
  • K821333 — ATRIAL J TEMPORARY PACING ELECTRODESS (June 2, 1982)
  • K812517 — CARDIAC PACING ELECTRODES (October 13, 1981)

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  • 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)