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510(k) K882551

AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 by Intl. Biomedics, Inc. — Product Code KLA

K882551 is an FDA 510(k) premarket notification submitted by Intl. Biomedics, Inc. for the device "AMBULATORY PH DATA RECORDER SYSTEM, APH-2000". The FDA issued a decision of Substantially Equivalent on October 12, 1988. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Intl. Biomedics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1988
Date Received
June 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Intl. Biomedics, Inc.

  • K854065 — INFANT LIFE SUPPORT MODULE-20 (January 16, 1986)

Other clearances for product code KLA

  • K242666 — Fecobionics Anorectal System (February 12, 2025)
  • K242304 — RED (December 6, 2024)
  • K234107 — Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (April 23, 2024)
  • K180135 — THD Anopress with THD SensyProbe (March 8, 2018)
  • K161785 — THD ANOPRESS (March 14, 2017)
  • K143031 — mcompass Biofeedback Anorectal Manometry System (July 7, 2015)
  • K120088 — MCOMPASS ANORECTAL MANOMETRY SYSTEM (March 29, 2012)
  • K062362 — SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CA (April 13, 2007)
  • K031617 — MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER (January 16, 2004)
  • K032138 — MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANOREC (October 9, 2003)

FDA data resources