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510(k) K942247

SMALL BOWEL ANALYSIS SOFTWARE by Sandhill Scientific, Inc. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1996
Date Received
May 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

Other clearances by Sandhill Scientific, Inc.

  • K111013 — ACEM (December 19, 2011)
  • K012232 — INSIGHT, MODEL S980000 (June 7, 2002)
  • K013951 — SANDHILL SCIENTIFIC PEDIATEC PH PROBE (February 28, 2002)
  • K002427 — SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 (June 22, 2001)
  • K990441 — INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 (May 12, 1999)
  • K984444 — INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 (January 11, 1999)
  • K961056 — BIOVIEW MODEL S960000 (June 6, 1996)
  • K941801 — ANALGRAPH (September 8, 1995)
  • K931963 — SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE (September 28, 1994)
  • K926218 — EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) (August 26, 1994)

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