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510(k) K883960

GIPHY MONITOR by Vascular Technology Incorporated — Product Code FFT

K883960 is an FDA 510(k) premarket notification submitted by Vascular Technology Incorporated for the device "GIPHY MONITOR". The FDA issued a decision of Substantially Equivalent on October 4, 1989. The device falls under product code FFT (Electrode, Ph, Stomach), a Class I device regulated under 21 CFR 876.1400. Vascular Technology Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1989
Date Received
September 20, 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 Vascular Technology Incorporated

  • K082870 — VTI INTRAOPERATIVE DOPPLER SYSTEMS (October 28, 2008)
  • K031091 — VTI 20 MHZ GATED DOPPLER (April 23, 2003)
  • K002990 — VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 (November 6, 2000)
  • K944764 — VTI DISPOSABLE PRESSURE DISPLAY SET (December 27, 1994)
  • K922738 — VTI OXYGEN ANALYZER (January 27, 1993)
  • K890058 — VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM (November 21, 1989)
  • K864583 — CARDIAC PERFORMANCE MONITOR (May 11, 1987)
  • K862114 — KHURI REGIONAL TISSUE PH MONITOR (June 25, 1986)
  • K862113 — NO. 100352 GALVANIC OXYGEN SENSOR (June 19, 1986)
  • K852275 — VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR (June 20, 1985)

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