Home / 510(k) Clearances / K841384

510(k) K841384

PROXIMA 1 PH MONITOR by American Endoscopy, Inc. — Product Code FFT

K841384 is an FDA 510(k) premarket notification submitted by American Endoscopy, Inc. for the device "PROXIMA 1 PH MONITOR". The FDA issued a decision of Substantially Equivalent on July 19, 1984. The device falls under product code FFT (Electrode, Ph, Stomach), a Class I device regulated under 21 CFR 876.1400. American Endoscopy, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1984
Date Received
March 20, 1984
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 American Endoscopy, Inc.

  • K853274 — AMERICAN DILATATION SYSTEM (October 17, 1985)
  • K833491 — ENDO BITE BLOCK (April 25, 1984)
  • K840818 — BIOPSY FORCEPS (April 13, 1984)
  • K833859 — TAMPONADE BALLOON CUFF (January 3, 1984)
  • K833492 — PERCUTANEOUS ENDOSCOPIC GASTROSCOPY (November 29, 1983)
  • K832458 — AUTOMATIC ENDOSCOPE (October 20, 1983)
  • K821818 — RETRIEVAL BALLOONS (September 24, 1982)
  • K821819 — PIGTAIL STENTS (August 20, 1982)
  • K822062 — BALL TIP COAGULATING ELECTRODES (August 19, 1982)
  • K821817 — PIGTAIL NASAL CATHETERS (August 10, 1982)

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