Home / 510(k) Clearances / K910694

510(k) K910694

ZINETICS INTERNAL REFERENCE PROBE by Zinetics Medical, Inc. — Product Code FFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1991
Date Received
February 19, 1991
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 Zinetics Medical, Inc.

  • K921682 — ZINETICS AMC (December 29, 1994)
  • K884527 — ZINETICS(R) EMC (February 28, 1989)
  • K883319 — HILL NASOGASTRIC TUBE (December 5, 1988)

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)