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510(k) K955018

TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR by Instrumentarium Corp. — Product Code FFT

K955018 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR". The FDA issued a decision of Substantially Equivalent on January 30, 1996. The device falls under product code FFT (Electrode, Ph, Stomach), a Class I device regulated under 21 CFR 876.1400. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1996
Date Received
November 2, 1995
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 Instrumentarium Corp.

  • K022630 — MODIFICATION TO FOCUS (October 9, 2002)
  • K001729 — FOCUS (July 13, 2000)
  • K001439 — ORTHOCEPH OC100 D (June 22, 2000)
  • K992385 — ORTHOPANTOMOGRAPH OP100D (September 28, 1999)
  • K981641 — MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA (July 17, 1998)
  • K962638 — TONOCAP, TC-200 AND ACCESSORY CATHETERS (April 4, 1997)
  • K961441 — TONOMETERED SLAINE BLOOD GAS CONTROL (April 30, 1996)
  • K934478 — ALPHA STEREO (January 31, 1995)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)
  • K930338 — ORTHOCEPH OC100 (April 27, 1993)

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)
  • 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)
  • K931963 — SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (September 28, 1994)

FDA data resources