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510(k) K883234

TONOMITOR (TM) + SUMP by Tonometrics, Inc. — Product Code FFT

K883234 is an FDA 510(k) premarket notification submitted by Tonometrics, Inc. for the device "TONOMITOR (TM) + SUMP". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code FFT (Electrode, Ph, Stomach), a Class I device regulated under 21 CFR 876.1400. Tonometrics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1988
Date Received
August 1, 1988
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 Tonometrics, Inc.

  • K920849 — TRIP CIC CATHETER (March 17, 1995)
  • K911825 — TRIP(TM) NASOGASTRIC SUMP CATHETER (July 23, 1991)
  • K890466 — SIGMOID TONOMITOR (April 21, 1989)

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