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510(k) K882551

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

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)

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